SASPI Ltd.
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Risk factors for detection of Pseudomonas aeruginosa in clinical samples upon hospital admission
Authors: Romeo Reyle
Abstract
Background/introduction: Antipseudomonal antibiotics are frequently used in patients admitted to hospitals. Many of these substances are classified as a reserve or watch status by the WHO. Inappropriate risk assessment of invasive detection of P. aeruginosa (PAE) can be a reason for overuse of antipseudomonal antibiotics. Therefore it is important to define relevant and specific risk factors for invasive PAE detection.
Objective: The objective of this study was to identify risk factors for invasive detection of PAE in patients upon hospital admission.
Methods: All patients 18 years of age and older with a detection of PAE and/or Enterobacterales in clinical samples taken within 48 h of admission to one of the hospitals of Charité Universitätsmedizin Berlin between 2015 and 2020 were included into this retrospective cohort study.
Results: Overall, we included a total of 27,710 patients. In 3,764 (13.6%) patients PAE was detected in clinical samples taken within 48 h after admission. The most frequently detected Enterobacterales was E. coli in 14.142 (51%) patients followed by Klebsiella spp. in 4.432 (16%) patients. Multivariable regression analysis identified that prior colonisation with a multi drug resistant PAE or detection of a PAE in clinical samples during a previous hospitalisation increased the risk for invasive detection of PAE (OR 39.41; 95% CI 28.54–54.39) and OR 7.87 (95% CI 6.60–9.38) respectively. Admission to a specialised ward for patients with cystic fibrosis was associated with an increased risk (OR 26.99; 95% CI 20.48–35.54). Presence of chronic pulmonary disease (OR 2.05; 95% CI 1.85–2.26), hemiplegia (OR 2.16; 95% CI 1.90–2.45) and male gender (OR 1.60; 95% CI 1.46–1.75) were associated with a modest increase in risk for presence of PAE.
Conclusion: Patients with a prior detection of P. aeruginosa or admission to a cystic fibrosis ward had the highest risk for invasive detection of P. aeruginosa. Adherence to specific risk scores based on local risk factors could help to optimize prescription of anti-pseudomonal antibiotics that categorized as reserve and watch.
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Unveiling antimicrobial stewardship competence among Italian nurses: results from a nationwide survey
Authors: Matteo Danielis
Abstract
Background: The development of nursing competencies in antimicrobial stewardship (AMS) is influenced by a two-dimensional model, encompassing both internal and environmental factors. In the context of Italian clinical nursing, this study aims to assess and measure these aspects.
Methods: Employing a cross-sectional online survey design, nurses from various clinical specialties in Italy were involved. The questionnaire assessed individual variables, knowledge, attitudes, practices, as well as structural and process-related variables influencing AMS. Statistical analyses were performed, encompassing descriptive statistics, Pearson correlation, and multiple linear regression.
Results: A total of 1,651 nurses aswered the survey, with a participation rate of 50.8%. The participant demographic revealed that 77% were female, and they had an average of 15 years of experience. Workplace and regional factors were found to significantly impact both AMS practices and attitudes. Surgical nurses reported higher practices scores (β = 0.467, P <.01), while critical care nurses scored lower (β= -0.398, P <.01). Regarding perceptions of structure, workplace characteristics significantly influenced nurses’ scores, indicating lower perceptions among surgical nurses compared to their medical counterparts (β= -0.315, P <.01).
Conclusions: The study reveals the intricate interplay between internal and external factors that impact nurses’ AMS competence. This underscores the urgent need for targeted interventions and education initiatives to enhance nurses’ AMS competencies. Specifically, addressing variations in settings and nurses’ behaviours becomes imperative for achieving improved patient outcomes.
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Implementing intranasal povidone-iodine in the orthopedic trauma surgery setting to prevent surgical site infections: a qualitative study of healthcare provider perspectives
Authors: Racila, A
Abstract
Background: Surgical site infections (SSIs) are associated with morbidity, mortality, and increased costs. Staphylococcus aureus is the most common cause of SSIs and approximately 30% of hemodialysis patients carry this organism in their nares. Unlike mupirocin, intranasal povidone-iodine (PVI) is applied only the day of surgery to prevent surgical site infections. Thus, intranasal PVI could be valuable in orthopedic trauma surgery settings where time to prepare a patient for surgery is limited.
Methods: We conducted a small phase IV post-marketing study from 2020 to 2021 in an academically affiliated hospital wherein staff administered intranasal PVI pre- and post-operatively to consenting patients undergoing orthopedic fixation procedures for traumatic fractures. Before implementing the PVI intervention, we conducted a human factors task analysis to determine the optimal time and hospital location to perform PVI decolonization for patients receiving these orthopedic fixation procedures. After the post-marketing study was completed, we conducted qualitative interviews with healthcare staff to determine barriers and facilitators that could affect staff members’ likelihood of administering PVI to patients. We aligned our inductive interview findings with strategies defined in Powell and colleagues’ Expert Recommendations for Implementing Change (ERIC) framework to facilitate generalizability and standardized reporting of implementation strategies.
Results: Our human factors task analysis identified the Day of Surgery Admissions (DOSA) as the appropriate context for PVI administration within surgical workflow, as there was downtime during this period and direct patient-provider communication could occur. Two DOSA nurses, one postoperative nurse, and one orthopedic trauma surgeon agreed to be interviewed. Facilitators of intranasal PVI administration included emphasizing the non-invasiveness of PVI nasal swabs to patients and emphasizing intranasal PVI efficacy to staff and patients. While the nurse participants felt that having PVI orders with other medication orders in the EMR helped them identify patients enrolled in the study and who required PVI, entering these orders increased the surgeon’s workflow and presented a time barrier.
Conclusions: Macro- and micro-level contextual factors should be considered when tailoring implementation to healthcare settings. Our findings reinforce prior work demonstrating the value of incorporating human factors engineering methodologies into infection control and prevention implementation approaches.
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Cytomegalovirus Infections in Patients Diagnosed with Inflammatory Bowel Disease
Authors: İnan-Hekimoğlu M
Abstract
Objective: The impact of cytomegalovirus (CMV) on inflammatory bowel disease (IBD) flares remains a matter of debate. This study aimed to evaluate patients with CMV infection who presented with IBD exacerbation in terms of diagnosis and treatment and investigate the importance of CMV DNA levels in colitis development.
Materials and Methods: Patients who were followed up with IBD and examined with clinical suspicion of CMV colitis at a university hospital between January 2016 and December 2021 were retrospectively scanned. This study included all patients who underwent colonoscopic biopsy with a preliminary diagnosis of CMV colitis and compared those with colitis detected histopathologically with those without colitis.
Results: Thirty-nine patients with IBD were included in the study. No statistically significant difference was observed regarding the two groups’ demographic data, clinical findings, and outcomes. The median serum CMV DNA level in patients with CMV colitis was 104 copies/mL, which was lower than in patients without colitis (1216 copies/mL) (p=0.008). Among patients with CMV colitis, CMV DNA levels were negative or low in 16 (61.5%).
Conclusion: In patients with IBD, CMV colitis may not always be accompanied by CMV viremia. Therefore, negative or low serum CMV DNA levels are not sufficient to exclude CMV colitis. In case of high clinical suspicion, further examinations should be planned.
Keywords: inflammatory bowel disease, cytomegalovirus, cytomegalovirus colitis, cytomegalovirus viremia
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Impact of Needle-Free Connector and Prefilled Flushing Syringe Shortage on CLABSI Rates in Pediatric Intensive Care
Authors: Devrim İ
Abstract
Objective: We aimed to discuss our experience of a higher incidence of catheter-associated bloodstream infections (CLABSIs) during the needle-free connector (NFC) and single-use prefilled flushing syringe (PFS) shortage.
Materials and Methods: Retrospective analyses were carried out to investigate the CLABSI rates at a tertiary training hospital from January 1, 2023, to December 31, 2023, and the study period included a three-month shortage of NFCs and PFSs in April and June 2023.
Results: The CLABSI rate for the three months was 5.94 per 1000 CL days from January 1 to March 31, 18.07 per 1000 CL days from April 1 to June 30, 5.42 per 1000 CL days from July 1 to September 30, and 6.52 per 1000 CL days from October 1 to December 31. Following the three-month shortage period, the rate of CLABSI significantly increased from 5.94 per 1000 CL days to 18.07 per 1000 CL days. After the shortage of needle-free connectors and single-use PFSs was resolved, the rate of CLABSI significantly decreased to 5.42 per 1000 CL days (p<0.001).
Conclusion: Even a three-month lack of NFC and PFS caused three-fold CLABSI. The efficacy and ongoing success of CLABSI prevention depend on maintaining the materials’ continuity.
Keywords: prefilled flushing syringes, needle-free connectors, catheter-associated bloodstream infections, pediatric intensive care unit
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A Precision Medicine Model for Targeted Antibiotic Therapy in Urinary Tract Infections: A Valuable Tool to Reduce Hospitalization Stay and the Time to Switch to Oral Treatment.
Authors: Cai T et al
Abstract
Background/Objectives: The management of urinary tract infections (UTIs) has become an increasingly challenging medical intervention. This study explores whether adoption of a precision medicine model could improve the management of acute uncomplicated pyelonephritis (uAPN) or complicated UTIs (cUTIs) compared with the standard of care approach, in hospitalized patients.
Methods: From January 2022 to March 2024, all patients affected by uAPN or cUTIs and attending urological institution were randomized to receive the following: antibiotic treatment according to guidelines and recommendations (standard of care group) or antibiotic treatment according to the precision medical model (intervention group). The main outcome measures were the rates of clinical success and the length of hospitalization. The time until switching to oral treatment was regarded as a secondary outcome measure.
Results: Eighty-three patients were enrolled in the standard of care group, while seventy-nine patients were enrolled in the intervention group. While the overall clinical success rate was similar in the two groups (75 vs. 72; p = 0.97), a statistically significant difference was observed between the two groups in terms of length of hospitalization (8 days vs. 5 days; p = 0.03) and time to switch to oral treatment (96 h vs. 72 h; p = 0.04). A statistically significant difference was found between the two groups regarding the need to change antimicrobial therapy during hospitalization [12 out of 80 vs. 6 out of 77; p = 0.04].
Conclusions: Adoption of the precision medicine model appears as a valuable means to improve the management of patients with uAPN and cUTIs. By reducing the period of hospitalization and the time to switch to oral treatment, the precision medicine model also improves antimicrobial stewardship in the management of UTIs.
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Ethiopian antimicrobial consumption trends in human health sector: A surveillance report 2020-2022.
Authors: Eshete H et al
Abstract
Background: Antimicrobial resistance (AMR) poses a severe global health threat, driven by the overuse and misuse of antimicrobials across the human, agricultural, and veterinary sectors. To combat this, global and national AMR prevention and containment strategies have been implemented, necessitating continuous monitoring of antimicrobial consumption (AMC) as an integral part of antimicrobial stewardship interventions.
Objective: This study aims to assess and analyze trends in AMC in Ethiopia from 2020 to 2022, with the goal of informing national and sub-national strategies to combat AMR.
Methods: A three-year AMC surveillance was conducted from 2020 to 2022. Data on locally manufactured and imported antimicrobials were collected from local manufacturers and Ethiopian Food and Drug Authority (EFDA)-regulated ports of entry. AMC was analyzed using the WHO GLASS AMC tool, with antimicrobials categorized using the WHO Anatomical Therapeutic Chemical (ATC) classification system. Consumption was measured in Defined Daily Doses (DDDs) and DDD per 1,000 inhabitants per day (DID), normalized using population estimates from the World Population Prospects for Ethiopia.
Results: The total AMC in Ethiopia increased from 432 million DDDs in 2020 to 485 million DDDs in 2022. The DID rose from 10.63 in 2020 to 11.34 in 2022. Antibacterials dominated consumption, comprising 98.87% in 2020, 95.96% in 2021, and 99.79% in 2022. Penicillins (J01C) and quinolones (J01M) were the most consumed antimicrobials. As per the Ethiopian AWaRe classification, the majority of antibacterial agents consumed were in the Access group, accounting for 71.14% in 2020, 70.65% in 2021, and 74.2% in 2022. Oral formulations consistently made up over 87% of the total consumption each year. Reliance on imported antimicrobials remained high, with imports comprising 64.76% in 2020 and 74.47% in 2022.
Conclusion: The increasing trend in AMC in Ethiopia from 2020 to 2022 underscores the urgent need to establish and strengthen national, sub-national, and facility-level surveillance and reporting systems to better monitor and ensure rational antimicrobial use.
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Assignments of antibiotic spectrum coverage scores of antibiotic agents approved in Japan: utilization of the days of antibiotic spectrum coverage.
Authors: Maeda M et al
Abstract
Integrating the automated collection of antimicrobial use metrics into national surveillance systems is vital for antimicrobial stewardship evaluation. The days of antibiotic spectrum coverage (DASC) serves as a quantitative metric for assessing de-escalation strategies. A major challenge is that DASC has not yet been integrated into the national surveillance system, partly owing to the omission of commonly used antibiotics in Japan in the initially developed antibiotic spectrum coverage (ASC) scores. This study aimed to establish ASC scores for antibiotics approved in Japan and generate data supporting their integration into the national surveillance system. Antibiotics approved in Japan that had not been assigned ASC scores in the prior study were identified. Their antimicrobial activity was assessed against 16 organism categories using the same methodology as the original study.The authors analyzed the correlation between the Access, Watch, Reserve (AWaRe) classification and ASC scores for antibiotics approved in Japan. The ASC scores had a range of 3-16, with a median of seven. The AWaRe classification was slightly correlated with ASC scores (Spearman’s ρ = 0.234). These findings highlight the significance of employing diverse antimicrobial use metrics for comprehensively evaluating antimicrobial stewardship. The results of this study will support stakeholders in implementing ASC scores into the national surveillance system.
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Wastewater based genomic surveillance key to population level monitoring of AmpC/ESBL producing Escherichia coli.
Authors: Waterlow NR et al
Abstract
Antimicrobial resistance (AMR) is a serious threat to global public health, but obtaining representative data on AMR for healthy human populations is difficult. Here, the authors leverage the power of whole genome sequencing (WGS) to screen AmpC- and extended-spectrum beta-lactamase (ESBL)-producing Escherichia coli from 77 composite samples obtained from 10 wastewater treatment plants across Finland. A high abundance of multidrug-resistant AmpC/ESBL-producing E. coli and significant differences in the diversity of AMR genes between the sampled cities was found. The in silico analysis of 73 short-read genome sequences shows the clonally diverse isolates consisting of 30 sequence types (STs), including the globally distributed pandemic ST131 clone. The CTX-M ESBL genes were detected in 86.3% (63/73) of the isolates concurrently with the blaTEM-1 (31.5%, 23/73) and blaOXA-1 (9.6%, 7/73) genes. The most prevalent ESBL genes were blaCTX-M-15 (46.6%, 34/73), blaCTX-M-27 (16.4%, 12/73), blaCTX-M-14 (4.1%, 3/73), and blaCTX-M-55 (4.1%, 3/73). Two isolates harboured the carbapenemase resistance gene, blaKPC-2 and blaNDM-1, respectively. In addition, WGS predicted phenotypic resistance against aminoglycosides, beta-lactams, cephalosporins, quinolones, sulfonamides, carbapenems, and polymyxins. The diversity of antibiotic- and stress-resistance genes correlated with the clinical incidence reported in the Finnish AMR report. Core-genome MLST revealed two wastewater genomic clusters but no genomic clusters among human and wastewater ST131 isolates. The findings suggest the circulation of distinct clonal lineages of AmpC/ESBL-producing E. coli across Finland, with variations in AMR gene diversity and abundance by wellbeing service county. Also, the findings underscore the fact that wastewater surveillance could be key to population-level monitoring of AmpC/ESBL-producing Escherichia coli and can serve as complementary data to guide public health decisions. The authors propose longitudinal WGS-based epidemiology as an economically feasible approach for global AMR surveillance, pathogen evolution, and prediction of AMR.
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Antimicrobial resistance of bacterial pathogens isolated from cancer patients: a systematic review and meta-analysis.
Authors: Waterlow NR et al
Abstract
Background: Antimicrobial resistance (AMR) is a major threat to global public health, limiting treatment options for infections. AMR is particularly life-threatening for cancer patients, who are at increased risk of antibiotic-resistant infections. This review presents the first comprehensive data on the prevalence of AMR in major bacterial pathogens isolated from cancer patients.
Method: An extensive search was conducted in PubMed, Scopus, and Web of Science, focusing on studies published in English from 2000 to 2024. A single-group meta-analysis was performed to determine the resistance prevalence of major bacterial species.
Results: One hundred thirty-two full-text articles were included in the systematic review, and studies on haematological cancer patients were the most common (36.4%). The major bacterial pathogens reported were Escherichia coli, Klebsiella pneumoniae, Staphylococcus aureus, Acinetobacter baumannii, Pseudomonas aeruginosa, Enterococcus faecium, Streptococcus pneumoniae and Enterobacter spp. For E. coli, resistance prevalence was highest for penicillins (81.84%), followed by cotrimoxazole (65.79%) and monobactams (61.61%). For K. pneumoniae, the highest prevalence of resistance was observed for penicillins (98.99%), followed by cotrimoxazole (70.92%). Acinetobacter baumannii had high resistance prevalence to multiple antimicrobial classes, including third-generation cephalosporins (84.10%), fourth-generation cephalosporins (80.75%), carbapenems (82.58%), fluoroquinolones (80.37%), beta-lactam-beta-lactamase inhibitors (79.15%), cotrimoxazole (75.77%), and aminoglycosides (64.05%). Enterobacter spp. and Enterococcus faecium showed high resistance prevalence to penicillins at 91.77% and 90.64% respectively. P. aeruginosa had a high prevalence of resistance to third-generation cephalosporins (49.41%) while S. aureus showed high prevalence to macrolides (55.63%) and methicillin (45.29%).
Conclusion: This review indicated a high prevalence of antimicrobial resistance in bacterial pathogens isolated from cancer patients worldwide. The pronounced resistance prevalence observed, especially among ESKAPE pathogens, underscores the urgent need to improve infection prevention and antimicrobial stewardship in cancer care globally.
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Nanomedicines as disruptors or inhibitors of biofilms: Opportunities in addressing antimicrobial resistance.
Authors: Lan J et al
Abstract
The problem of antimicrobial resistance (AMR) has caused global concern due to its great threat to human health. Evidences are emerging for a critical role of biofilms, one of the natural protective mechanisms developed by bacteria during growth, in resisting commonly used clinical antibiotics. Advances in nanomedicines with tunable physicochemical properties and unique anti-biofilm mechanisms provide opportunities for solving AMR risks more effectively. In this review, the authors summarize the five “A” stages (adhesion, amplification, alienation, aging and allocation) of biofilm formation and mechanisms through which they protect the internal bacteria. Aimed at the characteristics of biofilms, they emphasize the design “THAT” principles (targeting, hacking, adhering and transport) of nanomedicines in their interactions with biofilms and internal bacteria. Furthermore, recent progresses in multimodal antibacterial nanomedicines, including biofilms disruption and bactericidal activity, and the types of currently available antibiofilm nanomedicines contained organic and inorganic nanomedicines are outlined and highlighted their potential applications in the development of preclinical research. Last but not least, the authors offer a perspective for the effectiveness of nanomedicines designed to address AMR and challenges associated with their clinical translation.
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A clinical trial of curcumin effect in comparison to metronidazole on the treatment of bacterial vaginosis
Authors: Sakine Mohamadi
Abstract
Bacterial vaginosis (BV) is the prevailing infection. With the growing resistance of vaginal infections to routinely prescribed antibiotics, herbal medicine can be helpful. Researchers have conducted to compare the efficacy of curcumin and metronidazole in the treatment of BV as natural product. This study was a double-blind randomized clinical trial that involving 100 married women aged 18-49 who were not pregnant that sought treatment at two private outpatient clinics from January to September 2021 recruited in study. Individuals who met Amsel’s clinical and paraclinical criteria for BV were randomly allocated to the intervention or control groups. Both groups were instructed to take their respective medications every 12 h for seven days. Subsequently, two weeks following the treatment, the efficacy of the treatment was assessed utilizing Amsel’s clinical and paraclinical criteria. The data was analyzed using SPSS 26. The data was analyzed using the intention-to-treat (ITT) approach. The clinical (discharge (RD: 0.21; CI95%: 0.17-0.90; P = 0.01), whiff test (RD: 0.31; CI95%: 0.19-0.98; P = 0.03), and pH (RD: 0.18; CI95%: 0.19-1.04; P = 0.03)) and paraclinical variables of Amsel criteria (clue cells (RD: 0.19; CI95%: 0.13-1.03; P = 0.02) showed significant differences between groups. The curcumin consumer group exhibited a complete improvement rate of 82%, in contrast to the metronidazole group which had a rate of 42% two weeks after intervention. This study found curcumin have comparable efficacy to metronidazole in treating BV while demonstrating superior effectiveness and fewer adverse effects in alleviating symptoms.
Keywords: Bacterial vaginosis; Curcumin; Metronidazole.
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Completion of tuberculosis preventive treatment with 300 mg vs. 100 mg isoniazid tablets: a pragmatic randomized clinical trial
Authors: João Paulo Cola
Abstract
Background: Monotherapy with the drug isoniazid (INH) was for a long time the main therapeutic regimen used for tuberculosis preventive treatment (TPT). Research is progressing into the use of new therapeutic regimens that provide more complete TPT. The objective was to analyze the completion and safety of TPT with the drug INH in the form of 300 mg tablets.
Methods: Pragmatic, randomized, non-blinded, multicenter clinical trial conducted in Brazil from January 2019 to December 2022. Subjects over the age of 18 years with an indication for TPT was included and those whose index case of active tuberculosis was in retreatment, multidrug-resistant and extremely resistant, transferred, and people deprived of their liberty was excluded. The intervention was TPT with 1 INH 300 mg tablet and the control group with 3 INH 100 mg tablets. The primary outcome was TPT completion. Pearson’s chi-square test was used to analyze the association of TPT completion. The risk of TPT completion was estimated by Poisson regression. The mean treatment effect was calculated. The results were expressed as a risk ratio (RR) with a 95% confidence interval (95%CI).
Results: A total of 207 individuals were included, 103 (49.7%) in the intervention group. Seventy-two (69.9%) of the individuals who used INH 300 mg completed TPT. The risk ratio for completing TPT was 1.39 times higher in the group that used the INH 300 mg treatment (RR 1.39, 95%CI 1.08 to 1.79). The mean effect of the intervention was 19% (Coefficient 0.19, 95%CI 0.06 to 0.32). There was no significant difference in adverse events between the groups.
Conclusion: The pragmatic use of INH 300 mg in TPT showed a positive effect on the treatment completion rate and is a safe presentation for use in INH monotherapy regimens.
Trial registration: The protocol is registered in the Brazilian Registry of Clinical Trials under the code RBR-2wsdt6 in September 2019 10th.
Keywords: Isoniazid; Latent tuberculosis; Mycobacterium tuberculosis infections; Pragmatic clinical trial; Preventive treatment of tuberculosis.
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Efficacy and Safety of 4-Month Rifapentine-Based Tuberculosis Treatments in Persons with Diabetes
Authors: Ekaterina V Kurbatova
Abstract
A previous study demonstrated noninferior efficacy of 4-month rifapentine/moxifloxacin regimen for tuberculosis (TB) treatment compared with the standard regimen. We explored results among study participants with diabetes. Among 2,516 randomized participants, 181 (7.2%) had diabetes. Of 166 participants with diabetes in the microbiologically eligible analysis group, 26.3% (15/57) had unfavorable outcomes in the control regimen, 13.8% (8/58) in the rifapentine/moxifloxacin regimen, and 29.4% (15/51) in the rifapentine regimen. The difference in proportion of unfavorable outcomes between the control and rifapentine/moxifloxacin arms in the microbiologically eligible analysis group was -12.5% (95% CI -27.0% to 1.9%); the difference between the control and rifapentine arms was 3.1% (95% CI -13.8% to 20.0%). Safety outcomes were similar in the rifapentine/moxifloxacin regimen and control arms. Among participants with TB and diabetes, the rifapentine/moxifloxacin arm had fewest unfavorable outcomes and was safe. Our findings indicate that the rifapentine/moxifloxacin regimen can be used in persons with TB and diabetes.
Keywords: United States; antimicrobial resistance; bacteria; diabetes; moxifloxacin; phase 3 clinical trial; respiratory infections; rifapentine; tuberculosis and other mycobacteria.
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Micafungin versus Amphotericin B in treatment of invasive fungal infection in preterm neonates: a randomized control trial
Authors: Mariam John Amin Ibrahim
Abstract
Background: Micafungin, Amphotericin B, and Fluconazole are the primary therapeutic agents employed to address invasive fungal candidiasis in neonates. Resistance to fluconazole is gradually developing in neonatal intensive care units. We aimed to conduct a comparative analysis of Micafungin and Amphotericin B in terms of their effectiveness and safety in the treatment of invasive fungal infections in neonates.
Methods: Fifty-six preterm neonates with invasive fungal infection proven by fungal culture and who had received fluconazole for at least one week were included in our study and were divided randomly into two groups. Micafungin group: twenty-eight preterms received Micafungin at a dose of 8 mg/kg/day for 14 days. Amphotericin B group: twenty-eight preterms received amphotericin B at a dose of 1 mg /kg/day for 14 days. Clinical and laboratory follow up by fungal culture were performed after 14 days.
Results: Neonates in the Micafungin group showed significant increased percentage for complete cure of the fungal infection compared to Amphotericin B group 18(64.3%) vs. 10(35.7%) respectively and decreased percentage of incomplete cure 10(35.7%) vs. 18(64.3%) respectively with p-value 0.030. A higher percentage of neonates were completely cured for both candida albicans (65.2%) and non-albicans (60%) in the micafungin group. Duration of respiratory and circulatory support was significantly shorter also. No additional drug side effects were observed with Micafungin except for mild hypomagnesemia. There was an increase in blood urea nitrogen with Amphotericin B.
Conclusion: Micafungin is effective and well tolerated for the treatment of invasive fungal infections in preterm neonates.
Trial registration: The current study was approved by clinicaltrials.org and the protocol ID NCT06413056 was retrospectively registered in on 11th of march 2024. https://clinicaltrials.gov/study/NCT06413056?cond=micafungin%20in%20neonates&rank=2 .
Keywords: Amphotericin B; Candida non albicans; Invasive fungal infection; Micafungin; Neonates; Preterm.
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Effectiveness and safety of levofloxacin in the treatment of community-acquired pneumonia: A systematic review and meta analysis
Authors: Fengchun Song
Abstract
This study was conducted to evaluate the efficacy and safety of levofloxacin in the treatment of community-acquired pneumonia (CAP), and to provide a more reliable medication guide for the treatment of community-acquired pneumonia. Clinical studies of levofloxacin for CAP were searched through online literature databases, and the final literature for analysis was identified after screening by inclusion and exclusion criteria. The quality of the literature was assessed according to the risk of bias assessment criteria of the Cochrane system. Literature information was extracted and meta-analysis was performed using RevMan software. The observational indicators were clinical cure rate, microbiologic (bacteriologic) success rate, adverse event rate, and mortality rate. After screening, a total of 8 papers were included in the study, totaling 2,272 study subjects, of which 1,155 patients who received levofloxacin treatment were considered as the study group. 1117 patients who received other antimicrobial drugs were considered as the control group. The literature was evaluated to have a low risk level and a high reference value. The results of meta analysis showed that there was no significant difference in the clinical cure rate, microbiologic (bacteriologic) success rate, adverse event rate and mortality rate between the study group and the control group (P>0.05).As a result of the study, it was concluded that: levofloxacin has significant efficacy and safety in the treatment of CAP, and other antimicrobial drugs (e.g., moxifloxacin) have comparable efficacy and higher safety than levofloxacin, which provides a more diversified solution for the treatment of CAP.
Keywords: Adverse events; Community-acquired pneumonia; Levofloxacin.
African Journal of Reproductive Health © 2025.
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The global prevalence of antibiotic self-medication among the adult population: systematic review and meta-analysis
Authors: Tigist Gashaw
Abstract
Background: Antibiotic self-medication (ASM) is when a person takes antibiotics without a prescription or consulting a healthcare professional. These practices contribute to the misuse of medicines and antibiotic resistance which is a growing global health threat that can lead to longer hospital stays, higher healthcare costs, and increased mortality rates. Though various studies have been conducted on ASM in different countries, there has not yet been a systematic review that comprehensively assesses the problem in the entire globe. Hence, this systematic review and meta-analysis aimed to evaluate the global pooled prevalence of antibiotic self-medication and the reasons for its practice.
Method: A systematic search of electronic registers and databases was conducted on PubMed, Medline, Embase, Scopus, Web of Science, Google Scholar, and gray literature including institutional repositories, and national health databases. It used carefully selected keywords and indexing terms in the past ten years. The Joanna Briggs Institute’s critical checklist extracted relevant data after appraisal. Narrative analysis was used for descriptive data while Comprehensive Meta-Analysis (CMA) Software was used to analyze quantitative data. Statistics were used to look for heterogeneity, publication bias, and correlations. Sensitivity tests and sub-group analysis were employed to compare outcomes. A p-value < 0.05 was considered significant in all cases.
Results: Seventy-one studies were included in this systematic review and meta-analysis. The total number of participants was 63,251 with sample sizes ranging from 110 to 15,526. In primary outcomes, ASM ranged from 0.65 to 92.2%. The pooled prevalence of ASM globally was 43.0% (95% CI: 38.0, 48.1%). A high degree of heterogeneity across studies was shown with I2 = 99.2%, p < 0.001 assuming a random effect model. In subgroup analysis, the highest ASM pooled prevalence was 55.2% (95% CI: 47.2, 63.2) in sub-Saharan Africa followed by the Middle East, North Africa, and Greater Arabia at 48.3% (95% CI: 38.3, 58.4), Europe at 34.7% (95% CI:18.0, 56.4), and Asia at 25.8% (95% CI: 18.6, 34.6). Students have been identified as the major users of ASM at 62.1% (95% CI: 53.7, 69.7). The meta-regression showed a coefficient of 0.0365, -0.0117, and -0.0001 for a year of publication, recall time, and total sample size, respectively. Publication bias was demonstrated from the asymmetrical distribution of the funnel plot, and the Eggers regression p-value was greater than 0.05 (0.264). Moreover, knowledge of antibiotics (46.19% (95% CI: 27.99, 65.46)), previous successful experiences (39.13% (95% CI: 30.13, 48.93)), and perceiving illness as minor (38.10% (95% CI: 27.19, 50.37)) were the top three reasons pooled proportion for practicing ASM.
Conclusion: ASM practice was higher among African and student users. The previous successful experience was the most frequent reason reported. Educational level, gender, and age were often mentioned as predictor factors. Hence, designing interventional approaches that consider the different burdens among the target population and tackle the reasons for the practices might benefit averting antimicrobial resistance.
Keywords: Antibiotics; Global; Meta-analysis; Pooled prevalence; Self-medication; Systematic review.
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Tebipenem pivoxil as an alternative to ceftriaxone for clinically non-responding children with shigellosis: a randomised non-inferiority trial protocol
Authors: Sharika Nuzhat
Abstract
Introduction: Shigellosis is the second leading cause of diarrhoeal deaths among children worldwide. Oral azithromycin and intravenous ceftriaxone are the recommended first-line and second-line therapies for shigellosis in Bangladesh, respectively, but growing antibiotic resistance will require new antibiotic options. Tebipenem pivoxil, an orally administered carbapenem antibiotic with activity against many strains of antibiotic-resistant bacteria, may be a viable option.
Methods: A phase IIb randomised controlled trial was planned to determine the efficacy and safety of oral tebipenem pivoxil, compared with intravenous ceftriaxone, for children with Shigella diarrhoea unresponsive to the first-line antibiotic therapy. We will enrol 132 children in the trial (66 in each arm). Children from Bangladesh aged 24-59 months suspected of having Shigella diarrhoea, with no clinical improvement within 48 hours of starting first-line therapy, will be randomised to a 3-day course of intravenous ceftriaxone (50 mg/kg, once a day) or a 3-day course of oral tebipenem pivoxil (4 mg/kg, three times a day). The children will be evaluated for key clinical, microbiological and safety outcomes during the subsequent 30-day period. Clinically, failure at day 3 will be defined as the presence of fever (axillary temperature ≥38°C), diarrhoea (three or more abnormally loose or watery stools in the last 24 hours), blood in stool, or abdominal pain/tenderness at day 3 of follow-up or death or hospitalisation prior to day 3. It is hypothesised that children treated with tebipenem pivoxil will have no worse clinical and microbiological failure rates compared with ceftriaxone.
Ethics and dissemination: This study protocol was approved by the institutional review board of the International Centre for Diarrhoeal Disease Research, Bangladesh, which comprises a research review committee and an ethics review committee. In addition, the use of tebipenem pivoxil in shigellosis was approved by the Directorate General of Drug Administration of Bangladesh.
Trial registration number: NCT05121974.
Keywords: CLINICAL PHARMACOLOGY; Clinical Trial; Paediatric gastroenterology; Protocols & guidelines.
Other specific DSP article suggested by Editorial Board
Vonoprazan-Amoxicillin Dual Therapy Versus Drug Sensitivity-Based Individualized Therapy as a Rescue Regimen for Helicobacter pylori Infection: A Multicenter, Randomized Controlled Trial
DOI: 10.1111/hel.70009
Authors: Yu-Xiang Liu
Abstract
Objective: Vonoprazan is a novel potassium-competitive acid blocker (P-CAB) that offers several advantages, such as fast onset time and strong acid inhibition, in the treatment of Helicobacter pylori infection. This study aims to evaluate the efficacy, adverse reactions, and compliance of the 14-day vonoprazan-amoxicillin dual therapy versus drug sensitivity-based individualized therapy in the retreatment of H. pylori infection.
Methods: This multicenter, open-label, randomized, controlled non-inferiority study enrolled 240 adult patients who previously failed anti-H. pylori treatment. These patients were randomly assigned to receive the 14-day vonoprazan-amoxicillin dual therapy or drug sensitivity-based individualized therapy. The primary outcome was the eradication rate, and the secondary outcomes mainly included adverse events, patient compliance, antibiotic resistance rates, and risk factors that affected the eradication rate.
Results: The intention-to-treat (ITT) and per-protocol (PP) analyses revealed that the eradication rates for the vonoprazan-amoxicillin dual therapy and drug sensitivity-based individualized therapy were comparably high, with rates of 87.50% and 83.33%, respectively. Furthermore, the vonoprazan-amoxicillin dual therapy fulfilled the criteria for the non-inferiority test, when compared to individualized therapy. The incidence of adverse reactions was significantly lower in the vonoprazan-amoxicillin dual therapy group. Both groups showed similarly good compliance and comparable rates of antibiotic resistance. The previous treatment with a clarithromycin-containing regimen was identified as an independent risk factor for clarithromycin resistance.
Conclusion: The 14-day vonoprazan-amoxicillin dual therapy exhibits high eradication rates and low incidence of adverse reactions in retreated patients, indicating its effectiveness and safety as a rescue regimen for patients with H. pylori infection.
Keywords: Helicobacter pylori; amoxicillin; antibiotic resistance; eradication rate; potassium‐competitive acid blocker; rescue regimen; vonoprazan.
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A comparison of empiric therapy with cefazolin versus ceftriaxone for patients with complicated urinary tract infections in a tertiary care veterans affairs medical center
Authors: Paola Carcamo
Abstract
Background: Data are limited regarding use of narrow-spectrum agents for the treatment of complicated urinary tract infections (cUTIs). We sought to evaluate cefazolin compared with ceftriaxone for the empiric treatment of patients with cUTIs in an inpatient setting.
Methods: We conducted a retrospective, single-center, cohort study involving patients with cUTI treated with cefazolin or ceftriaxone at a Veterans Affairs (VA) medical center between November 1, 2019 and September 30, 2022. The primary outcome was 30-day clinical success, defined as resolution of signs and symptoms of infection without re-initiation of antibiotics during hospitalization or relapse within 30 days after cUTI diagnosis. Secondary outcomes included hospital length of stay and Clostridioides difficile infection (CDI) within 30 days of the end of antibiotic therapy.
Results: We identified 113 patients with cUTI treated with cefazolin (n = 52) or ceftriaxone (n = 61) meeting study criteria. The study arms had similar demographics, although patients treated with ceftriaxone more frequently had subjective fever on admission or nephrolithiasis while cefazolin-treated patients had more altered mental status as the only UTI symptom reported, urinary catheter, and had a single dose of another antibiotic prior to starting the study medication. Clinical success was achieved in 47/52 (90%) and 53/61 (87%) in the cefazolin and ceftriaxone groups, respectively (P = 0.56). Additionally, there were no statistically significant differences in length of stay and development of CDI.
Conclusions: In this retrospective cohort study of patients with cUTI at a VA medical center, empiric therapy with cefazolin appears to be a safe and effective treatment option.
Keywords: Antimicrobial stewardship; Cefazolin; Ceftriaxone; Complicated urinary tract infections; Inpatient.
© 2025. This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply.
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Revisiting Antimicrobial Stewardship in the Paediatric Intensive Care Unit: Insights from an Unconventional Approach
Authors: C Liberati
Abstract
Background: Patients admitted to the Paediatric Intensive Care Unit (PICU) constitute a high-risk group with a heightened likelihood of receiving inappropriate antimicrobial prescriptions. This study describes an Antimicrobial Stewardship Programme (ASP) in the PICU of a tertiary hospital in Italy.
Method: A pre-post quasi experimental study was conducted between 01/01/2019 and 31/12/2022 in the PICU of the Department for Women’s and Children’s Health, University Hospital of Padua. The ASP intervention started in February 2021 by a multidisciplinary team using the “handshake” approach. The population included all patients admitted to the PICU. The primary outcome was antibiotic consumption measured as days of therapy administered (DOTs)/1000 patient-days. An interrupted time series analysis was used to assess the trend in antibiotic prescribing before and after the intervention.
Results: 616 patients (episodes) were admitted in the pre-intervention phase (Jan 2019 – Jan 2021) and 602 patients in the post-intervention phase (Feb 2021 – Dec 2022). For overall antibiotic consumption, the ASP implementation resulted in a significant monthly decrease of 3.0% (p< 0.0001). Monthly reductions for higher consumption antibiotics were: meropenem 4.9% (p=0.009), glycopeptides 3.8% (p=0.014), piperacillin-tazobactam 4.8% (p=0.034). The consumption of third-generation cephalosporins and amikacin did not significantly vary.
Conclusions: The ASP intervention was effective in reducing the consumption of antimicrobials in such a complex setting. These results show the importance of antimicrobial stewardship in the scenario of critically ill children.
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Strategies, personnel, and diversity of pediatric antimicrobial stewardship programs in the United States: Strategies and composition of US pediatric ASPs
DOI: 10.1017/ash.2025.18
Authors: Christina S Manice 1 2 3, Alexander S Plattner 4 5, Edan Leshem 4, Jason G Newland 6,
Abstract
Objective: We sought to characterize US pediatric antimicrobial stewardship programs (ASPs), including their hospital demographics, staffing, funded full-time equivalents (FTEs) by hospital size, and relative emphasis on recommended stewardship strategies. We examined the self-reported characteristics of ASP personnel with regard to discipline, race, ethnicity, gender identity, and years of experience in antimicrobial stewardship.
Design: Descriptive two-part survey.
Setting: Pediatric ASPs at hospitals participating in Sharing Antimicrobial Reports for Pediatric Stewardship (SHARPS), a pediatric quality improvement collaborative of >70 children’s hospitals.
Participants: Survey distributed to 82 US pediatric ASPs, excluding hospitals without pediatric ASPs. Part I completed by ASP leader (physician or pharmacist). Part II distributed to ASP team members.
Methods: Part I addressed hospital demographics, ASP funding, and program choices related to the CDC’s 2019 Core Elements of Hospital Antibiotic Stewardship Programs. Part II requested that participants anonymously self-identify race, ethnicity, gender identity, training, and duration of ASP experience. Descriptive statistics performed.
Results: Sixty-two ASPs responded: 61 (98%) with formal ASP, 40 (65%) from freestanding children’s hospitals. 40 (65%) co-led by an ASP physician and pharmacist. 60 (97%) reported dedicated inpatient physician FTE, 57 (92%) dedicated inpatient pharmacist FTE. Most programs (35 [58%]) reported inadequate staffing support. The 125 ASP professionals who completed Part II predominantly self-reported as White (89 [71%]), with fewer self-reporting as Asian (9 [15%]) or Black (4 [3%]).
Conclusion: US pediatric ASPs have achieved substantial progress in meeting the CDC Core Elements, but many report insufficient resources. We identified underrepresentation in the ASP workforce.
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An inpatient antimicrobial stewardship team driven penicillin allergy delabeling protocol for minimal and low-risk penicillin allergic patients
DOI: 10.1017/ash.2025.7
Authors: Shivanjali Shankaran
Abstract
Inappropriate penicillin allergy labeling results in suboptimal or excessive broad spectrum antibiotic use. In this multidisciplinary project, the antimicrobial stewardship team safely delabeled 71.4% of hospitalized patients approached. Similar programs may also be able to delabel minimal or low-risk penicillin allergic patients without formal allergy consultation.
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Stewarding beyond the 9-5: Implementation of overnight review of rapid blood culture identification panel results by intensive care unit pharmacists
DOI: 10.1017/ash.2025.7
Authors: Sarah M Arduser Sindelar
Abstract
Rapid blood culture identification is most effective with antimicrobial stewardship feedback, which is limited during non-business hours. We implemented overnight review of Blood Culture Identification 2 panel results by intensive care unit pharmacists and demonstrated reduced time to evaluation (3.6 vs 9.3 hours, P < .01).
© The Author(s) 2025.
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Conflict of interest statement
T.V.S. reports initiating grant support paid to his institution from BioMérieux as well as consulting for BioMérieux. S.J.B. reports receiving honorarium from BioMérieux for a presentation related to rapid diagnostic testing. All other authors report no conflicts of interest relevant to this article.
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Macro- and micro-influencers of antimicrobial costs…What do stewardship programs need to know?
DOI: 10.1017/ash.2025.38
Authors: Sheetal Kandiah
Abstract
The high cost of antimicrobials presents critical challenges for healthcare providers managing infections amidst the growing threat of antimicrobial resistance (AMR). High costs hinder access to necessary treatments, disproportionately affecting disadvantaged populations and exacerbating health disparities. High drug prices necessitate the use of less effective or more toxic alternatives, leading to suboptimal outcomes and prolonged hospitalizations. This, in turn, increases healthcare costs and undermines efforts to combat AMR. Equitable policies, national formularies, and cost caps for essential antimicrobials can ensure universal access to life-saving treatments and enable antimicrobial stewardship programs to ensure the best possible outcomes.
© The Author(s) 2025.