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A Dynamic Sugar-Selective Bacterial Nanopore for Targeted Antibiotic Transport
Authors: Sharavanakkumar Sk
Abstract
Bacterial porins are essential for molecule transport, yet their functionality in pathogens remains underexplored. Here, a monomeric porin CymAKp is identified and characterized from a pathogen Klebsiella pneumoniae, featuring a specialized constricted segment (1-25 residues) in the pore. Single-channel recordings reveal the formation of fluctuating CymAKp nanopores that exhibit gating in symmetrical and asymmetrical lipid bilayers. The movement of the constricted segment drives these gating events, and the deletion of this segment results in stable nanopores establishing dynamic functionality of the pores. Furthermore, it is shown that CymAKp functions as a sugar-selective nanopore, facilitating the permeation of cyclic hexasaccharide while excluding larger cyclic sugars. Aminoglycoside antibiotics, structurally similar to cyclic sugars, exploit this sugar-selective pathway for translocation, and their translocation kinetics is quantified. Remarkably, molecular dynamics simulations reveal two distinct translocation pathways: one for cyclic hexasaccharides, where the constricted segment is displaced, and another for antibiotics, where the constricted segment remains within the pore. Studies establish the charged affinity site and constricted segment role in the porin as key regulators of dynamic molecular transport in pathogenic porins and provide new insights for developing nanopore-based drug delivery systems.
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Bioactive Compounds as a Potential Inhibitor of Biofilm Production: An In silico Study to Identify Natural Hindrance Resources
Authors: Jai Gupta
Abstract
Background: Biofilm formation by microorganisms, specifically bacteria, threatens vari-ous fields, including biomedicine and the environment. The development of biofilms has associations with increased resistance to antimicrobial agents and immune responses; it poses a significant threat to human health. ESKAPE pathogens, a group of bacteria known for their multidrug resistance, are particularly adept at biofilm formation. This research explores strategies to combat biofilm-associated infections, with a focus on natural compounds as potential anti-biofilm agents.
Methods: The study investigates 23 natural compounds for their druglike properties in fighting against antibiotic-resistant biofilms. These compounds include flavonoids, terpenes, and alkaloids, and exhibit promising bioavailability and usage potential as ligands. Molecular docking analysis em-ploying AutoDock Vina was used to evaluate the binding affinities of these ligands to key biofilm-forming genes and membrane proteins in ESKAPE pathogens.
Results: Despite a few violations of a variety of established criteria, the overall safety and efficiency of oral drug reception are maintained, emphasizing their potential for further drug development. The results show specific ligands, such as Baicalin, Apigenin, Azadirachtin, Curcumin, Hyperforin, etc., demonstrating high binding energies against biofilm-associated proteins. This approach aligns with the pursuit of sustainable alternatives to combat biofilm-related infections.
Conclusion: Natural compounds like Baicalin, Apigenin, Azadirachtin, Curcumin, Hyperforin not only exhibit broad-spectrum coverage but also show reduced risks of resistance development com-pared to synthetic antibiotics. The integration of natural compounds into multifaceted strategies con-siders the complexities of the biofilm matrix, bacterial diversity, and pathogen characteristics, offer-ing a sustainable approach to address biofilm-associated infections.
Keywords: Biofilm; ESKAPE Pathogen; molecular docking; sustainable alternatives..
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Effectiveness of oral probiotics and metronidazole compared with oral probiotics and metronidazole pessaries in the treatment of bacterial vaginosis in Chinese women
Authors: Min Zhao
Abstract
Chinese guidelines recommend oral or metronidazole pessaries for treating bacterial vaginosis (BV). Although oral metronidazole has high bioavailability, it often causes adverse effects, which may be minimized by using the pessaries. This study compared the effectiveness, adverse effects, and recurrence rates between two groups of women receiving oral probiotics plus 200 mg metronidazole pessaries and those receiving oral probiotics plus 400 mg oral metronidazole. Women with BV were treated for 7 days with either regimen for one month. Both groups showed significant improvement in vaginal pH and Nugent scores (p < 0.0001), with greater improvement in vaginal pH in the pessary group. Oral metronidazole was associated with side effects, including metallic taste, headache, dizziness, and gastrointestinal disturbances, while pessaries caused vulvar itching. Recurrence at 12 months was lower in the pessary group compared to the oral group (24% vs. 37%, p = 0.0105). We conclude that probiotics combined with metronidazole (especially in pessary form) showed effective treatment outcomes with manageable side effects in Chinese women with BV.
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The safety and efficacy of a single dose of oral azithromycin given in labour to prevent skin and soft tissue infections in young infants in Fiji: a randomised controlled trial
Authors: Maeve Hume-Nixon
Abstract
Background: Prophylactic azithromycin in pregnancy has been shown to lower infections in birthing parents and newborns, particularly skin and soft tissue infections (SSTIs) which are common in Fiji. We aimed to determine the safety and efficacy of 2 g of oral azithromycin administered during labour on infant SSTIs.
Methods: This blinded, randomised placebo-control trial included healthy, pregnant adults and their infants presenting for delivery at a tertiary hospital in Suva, Fiji. Participants in labour were randomly assigned a single dose of 2 g of oral azithromycin or placebo in a 1:1 ratio, stratified by ethnicity. Active and placebo drugs were identical to mask treatment allocation. The primary outcome was cumulative incidence of infant SSTIs by 3 months of age. Intention-to-treat analysis was used and included participants with SSTI data collected at all visits. Safety outcomes were described as percentages by arm at specified time points.
Results: From June 2019 to January 2022, 2110 pregnant persons were enrolled and randomised, with 1059 and 1063 births in the azithromycin and placebo groups, respectively. 1671 infants were included in the primary analysis (816 in azithromycin and 855 in placebo group). We found a 27% decrease in infant SSTIs in the azithromycin group (5.8%; 95% CI 4.4-7.6) compared to placebo (7.8%; 95% CI 6.2-9.8), but the 95% confidence interval crossed the null value (RR 0.73; 95% CI 0.51-1.06). We observed similar numbers of serious adverse events in both arms, and no cases of infant hypertrophic pyloric stenosis.
Conclusions: There was a modest relative reduction in infant SSTIs but this was small in absolute terms with no statistically discernible difference. Our findings do not support routine intrapartum azithromycin prophylaxis for this outcome alone. However, the rates of SSTIs highlight the importance of prevention and timely treatment in Fiji.
Trial registration: 2019-04-18, ClinicalTrials.gov identifier: NCT03925480.
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The relationship between the eradication of Helicobacter pylori and the occurrence of stomach cancer: an updated meta-analysis and systemic review
Authors: Zhouhan Wu
Abstract
Objective: Helicobacter pylori (H. pylori) are classified as a Group 1 carcinogen by the International Agency for Research on Cancer (IARC), highlighting its well-established role in gastric carcinogenesis. While previous studies and systematic reviews suggest that H. pylori eradication may lower the incidence and mortality of gastric cancer, the evolving body of evidence necessitates continual reassessment. In light of newly available data, we conducted a comprehensive meta-analysis to evaluate the association between H. pylori eradication therapy and gastric cancer risk, aiming to strengthen the evidence base and inform clinical decision-making.
Method: We systematically searched the Cochrane Library, PubMed, Web of Science, and Embase up to December 2024, including only randomized controlled trials (RCTs) while excluding non-RCT studies. The target population comprised adults diagnosed with H. pylori infection who were either healthy or had previously undergone gastrectomy for gastric tumors. Eradication therapy served as the intervention, while placebo was the control. Eligible studies had a treatment duration exceeding seven days and a follow-up period of more than three years. The Cochrane risk-of-bias tool was used to assess methodological quality, and effect estimates were expressed as relative risk (RR) and the number needed to treat (NNT).
Outcomes: A total of 11 RCTs encompassing 104,786 individuals were analyzed. The meta-analysis revealed that H. pylori eradication significantly reduced gastric cancer risk (RR: 0.61; 95% CI: 0.47-0.79; NNT = 332). Subgroup analysis indicated that among healthy adults, the relative risk (RR) for the occurrence of gastric cancer was 0.67 (95% CI: 0.48-0.93; NNT = 476). In individuals who had undergone endoscopic mucosal resection, the reduction was even more pronounced (RR: 0.51; 95% CI: 0.36-0.71; NNT = 21). Although stomach cancer-specific mortality showed a slight decline (RR: 0.84; 95% CI: 0.69-1.01), all-cause mortality remained statistically unchanged (RR: 1.00; 95% CI: 0.89-1.13).
Conclusion: Our findings support H. pylori eradication as an effective strategy for reducing gastric cancer incidence, particularly in East Asian populations. While the effect on overall mortality remains inconclusive, the observed reduction in gastric cancer-related mortality highlights the potential clinical significance of eradication therapy as a preventive measure. Further well-designed, long-term studies are warranted to reinforce the evidence base and optimize clinical recommendations.
Keywords: Helicobacter pylori; Eradication; Meta-analysis; Stomach cancer.
© 2025. The Author(s).
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Bringing malaria diagnosis and treatment closer to the people: economic rationale for expanding malaria community case management to all ages in a rural district in Madagascar
Authors: Walter Ochieng
Abstract
Background: Expanding malaria community case management (mCCM) to all ages could shift the point-of-care to the community leading to improved healthcare access in underserved populations. This study assesses the economic viability of such an expansion in Farafangana district, Madagascar.
Methods: A cluster-randomized trial was conducted across 30 health centres and the 502 community health workers (CHW) in their catchment areas, with the intervention arm implementing the age-expanded mCCM intervention. CHWs across both arms received training, supplies, and supervision to manage malaria. An economic evaluation assessed cost-effectiveness from health sector and societal perspectives, measuring outcomes in disability-adjusted life years (DALYs) averted. The impact of CHW compensation and economic risks were evaluated using sensitivity analyses.
Results: Without CHW compensation, annual costs were $794,000, primarily for antimalarials and diagnostic tests. Incremental cost-effectiveness ratios (ICERs) per DALY averted ranged from -$21.86 to $212.42. From a societal perspective, the ICER was -$135.64, and -$243.29 including mortality benefits, meaning the intervention was cost-saving. The programme could avert 99.6 deaths and 3,721.7 DALYs annually, yielding $1,172,283 in net economic benefits. Sensitivity analyses supported these findings.
Conclusions: Age-expanded mCCM is highly cost-effective and can enhance malaria treatment access in resource-limited settings.
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Adherence to anti-malarials among patients diagnosed with malaria in East Africa: a systematic review and meta-analysis
Authors: Jackline D Nkoma
Abstract
Background: East Africa continues to bear a significant share of the global malaria burden, despite its commitment to the malaria elimination goal of 2030. Furthermore, reported variations in adherence to anti-malarials hamper the regional effort in malaria elimination. Moreover, the region has no comprehensive and comparable adherence estimates for policymakers to set priorities, target control strategies, and evaluate the effectiveness of interventions. Hence, this systematic review synthesized the regional adherence estimate for East Africa.
Methods: Authors searched articles from PubMed, Science Direct, CINHAL, Scopus, and Google Scholar. Two authors independently assessed retrieved studies for eligibility and risk of bias, then the adherence rate was pooled using the random effect model implemented in STATA. Publication bias was assessed using a funnel plot symmetry and the Egger test. Subgroup analysis was performed to explore the effect of the national and types of regimens on the overall estimate. Qualitative analysis was applied to explain factors that influence adherence.
Results: A total of 29 studies with 15 927 participants were included. The overall adherence rate was 70.30% (95% CI 61.93-78.67; 29 studies; I2 = 99.76%), with the highest level reported in Rwanda (100%, 95% CI 97.28-100.00) and lowest in Tanzania (6.99%, 95% CI 0.2.81-11.17). Furthermore, adherence was high for chloroquine plus sulfadoxine-pyrimethamine (96.27%, 93.87-98.66; one study). Recalling correct instructions and taking the first dose at the health facility had a positive influence on patient adherence.
Conclusion: On average, about three-quarters of malaria patients in East Africa adhere to their medications. In light of these findings, further interventional studies are needed to address low adherence to anti-malarials in the region. Moreover, adherence studies with the appropriate method of measurement are still needed to obtain a robust generalizable estimate in East Africa. Trial registration This review was registered at PROSPERO with the registration ID CRD42023410048.
Keywords: Adherence; Anti-malarials; East Africa; Malaria; Systematic review.
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Efficacy of Baloxavir Treatment in Preventing Transmission of Influenza
Authors: Arnold S Monto
Abstract
Background: Baloxavir marboxil (baloxavir) rapidly reduces influenza virus shedding, which suggests that it may reduce transmission. Studies of treatment with neuraminidase inhibitors have not shown sufficient evidence that they prevent transmission to contacts.
Methods: We conducted a multicountry, phase 3b trial to assess the efficacy of single-dose baloxavir treatment to reduce influenza transmission from index patients to household contacts. Influenza-positive index patients 5 to 64 years of age were randomly assigned in a 1:1 ratio to receive baloxavir or placebo within 48 hours after symptom onset. The primary end point was transmission of influenza virus from an index patient to a household contact by day 5. The first secondary end point was transmission of influenza virus by day 5 that resulted in symptoms.
Results: Overall, 1457 index patients and 2681 household contacts were enrolled across the 2019-2024 influenza seasons; 726 index patients were assigned to the baloxavir group, and 731 to the placebo group. By day 5, transmission of laboratory-confirmed influenza was significantly lower with baloxavir than with placebo (adjusted incidence, 9.5% vs. 13.4%; adjusted odds ratio, 0.68; 95.38% confidence interval [CI], 0.50 to 0.93; P = 0.01), with an adjusted relative risk reduction of 29% (95.38% CI, 12 to 45). The adjusted incidence of transmission of influenza virus by day 5 that resulted in symptoms was 5.8% with baloxavir and 7.6% with placebo; however, the difference was not significant (adjusted odds ratio, 0.75; 95.38% CI, 0.50 to 1.12; P = 0.16). Emergence of drug-resistant viruses during the follow-up period occurred in 7.2% (95% CI, 4.1 to 11.6) of the index patients in the baloxavir group; no resistant viruses were detected in household contacts. No new safety signals were identified.
Conclusions: Treatment with a single oral dose of baloxavir led to a lower incidence of transmission of influenza virus to close contacts than placebo. (Funded by F. Hoffmann-La Roche and others; CENTERSTONE ClinicalTrials.gov number, NCT03969212.).
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A Systematic Review and Meta-Analysis of the Efficacy of Biosecurity in Disease Prevention and Control in Livestock Farms in Africa
DOI: 10.1155/2024/8683715
Authors: Ronald Vougat Ngom
Abstract
In Africa, livestock production plays a crucial role for sustainable food security and economic growth. However, the development of this sector has been delayed by livestock diseases, one of the main constraints, which can cause important production and economic losses. To overcome these constraints, farmers extensively use antimicrobials, which in turn can lead to antimicrobial resistance (AMR), one of the main threats to global health and food security. Biosecurity has been identified as a key strategy to reduce livestock diseases. Therefore, the current systematic review and meta-analysis, conducted according to the Cochrane guideline, aimed at determining the efficacy of biosecurity in preventing and controlling infectious diseases in livestock farms in Africa. Of the 1408 records retrieved from five different databases, only 16 met the inclusion criteria. These studies were conducted in Egypt (31.2%), Nigeria (31.2%), Uganda (18.8%), Ethiopia (12.5%) and Tunisia (6.3%) and concerned poultry (62.4%), pigs (18.8%) and cattle (18.8%). Investigations focused mainly on avian influenza (AI) (15.0%) and coccidiosis (10.0%) in poultry and African swine fever (ASF) (10.0%) in pigs. In poultry farms, the results of the pairwise meta-analysis showed that biosecurity measures related to visitors and farmworkers could be effective at reducing the risk of introduction and spread of AI viruses (odds ratio [OR] = 0.48; 95% confidence interval [CI] 0.28-0.82). Moreover, inadequate biosecurity seemed to be a factor promoting coccidiosis (OR = 4.20; 95% CI 2.4-7.4) and AI (OR = 1.74; 95% CI 1.23-2.48). Prevention of ASF was significantly associated with the application of biosecurity measures related to animals’ transport, removal of carcasses and manure (OR = 0.33; 95% CI 0.12-0.88). Despite their importance, these findings cannot be translated to the entire African continent, since no studies were available for more than 90% of its countries. More research should be carried out to fill in the gaps identified by this review.
Keywords: Africa; African swine fever; avian influenza; biosecurity; cattle; coccidiosis; pigs; poultry; review.
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Metagenomic Next-Generation Sequencing Improves the Diagnosis Efficiency of Mixed Periprosthetic Joint Infections.
DOI: 10.2147/IDR.S516650
Authors: Ronald Vougat Ngom
Abstract
Purpose: To explore the clinical significance of metagenomic next-generation sequencing (mNGS) in the diagnosis of mixed periprosthetic joint infections (PJI).
Methods: The data pertaining to patients suspected of PJI who underwent arthroplasty at our hospital between January 2020 and June 2024 were analyzed. Patients included in the study were subjected to microbial culture and mNGS analyses to evaluate the efficacy of mNGS in diagnosing mixed PJIs.
Results: Among the 44 PJI patients included, 20 (45.45%) were culture-positive, and 35 (79.55%) were mNGS-positive. Compared to microbial culture, mNGS demonstrated significantly higher sensitivity, negative predictive value, and accuracy (79.55% vs 45.45%, 55.00% vs 35.14%, and 80.70% vs 57.89%, respectively; all P<0.05). However, the specificity of mNGS was significantly lower than culture (84.62% vs 100.00%, P<0.05). For mixed PJIs, the sensitivity of mNGS was notably higher, albeit with lower specificity and positive predictive value compared to microbial culture (72.23% vs 27.27%, 85.19% vs 100.00%, 66.67% vs 100.00%, respectively; all P<0.05). mNGS enables more sensitive detection of co-pathogens in mixed PJI, accelerating targeted therapy and reducing inappropriate broad-spectrum therapy. While its lower specificity requires clinical integration, it clarifies complex diagnoses and streamlines stewardship for improved outcomes.
Conclusion: mNGS is a promising technique for rapidly and accurately detecting co-pathogens in mixed PJI.
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Accelerating antimicrobial stewardship: An AI-CDSS approach to combating multidrug-resistant pathogens in the era of increasing resistance.
Authors: Lin TH et al
Abstract
Objectives: The World Health Organization has identified Klebsiella pneumoniae (KP) and Pseudomonas aeruginosa (PA) as significant public health threats owing to high antibiotic resistance. Traditional antibiotic susceptibility testing (AST) methods, crucial for determining the most suitable treatment regimen, typically require approximately 48-96 h (2-4 days) to yield results, including bacterial culture, rapid identification via matrix-assisted laser desorption/ionization-time of flight mass spectrometry (MALDI-TOF MS), and subsequent AST, which is too long for urgent clinical decisions. Here, an artificial intelligence-clinical decision support system (AI-CDSS) was developed utilizing machine learning to analyze MALDI-TOF MS data for antibiotic resistance prediction for these pathogens.
Methods: From 165,299 bacterial specimens, 12,967 KP and 9,429 PA cases was selected. Predictive models, the core of the AI-CDSS, were built using advanced machine learning algorithms, such as the random forest classifier (RFC) and light gradient boosting machine (LGBM), with GridSearchCV and 5-fold cross-validation optimization and robustness.
Results: Both the RFC and LGBM models demonstrated strong predictive performance, with area under the curve values predominantly ranging from 0.91 to 0.95. Sensitivity, specificity, positive predictive value, and negative predictive value primarily exceeded 80 %, ensuring reliable detection of resistance patterns. The AI-CDSS was designed to provide real-time, clinically actionable recommendations, enabling targeted antibiotic selection up to one day faster than conventional AST.
Conclusions: Integrating MALDI-TOF MS with machine learning in AI-CDSS significantly enhanced clinical decision-making, representing a major advancement in the rapid management of infectious diseases and antimicrobial stewardship.
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In vitro activity of omadacycline against bacterial isolates from bone/joint infections and rare pathogens in the SENTRY Antimicrobial Surveillance Program (2015-2023).
Authors: Huband MD et al
Abstract
Objectives: Omadacycline is an aminomethylcycline (tetracycline class) antibacterial approved by the United States Food and Drug Administration (2018) for treatment of adults with acute bacterial skin and skin structure infection (ABSSSI) and community acquired bacterial pneumonia (CABP) caused by indicated organisms (oral and iv formulations). Omadacycline has activity against bacterial isolates expressing common tetracycline resistance mechanisms (ribosomal protection proteins and efflux pumps), which render older generation tetracyclines inactive. Omadacycline in vitro activity was assessed against 919 bacterial isolates collected from patients with bone/joint infections in the United States and Europe (2015-2023) and 3,945 rarely encountered bacterial pathogens from patients (multiple infection sites) in the United States (2015-2023) as part of the SENTRY Antimicrobial Surveillance Program.
Methods: Broth microdilution susceptibility testing followed Clinical and Laboratory Standards Institute M07 (2024) and M100 (2024) guidelines.
Results: Omadacycline demonstrated susceptibilities of ≥90.0% (FDA breakpoints) against Staphylococcus aureus (including MRSA), Staphylococcus lugdunensis, Enterococcus faecalis (including vancomycin-resistant), and streptococci including Streptococcus anginosus, Streptococcus pneumoniae, and Streptococcus pyogenes from patient with bone/joint infections. Omadacycline demonstrated potent in vitro activity against rare Gram-positive pathogens (multiple infection sites), inhibiting 97.3%, 91.3%, and 99.4% of uncommon staphylococci, streptococci, and enterococci isolates at or below current FDA approved ABSSSI breakpoints for S. aureus, S. pyogenes, and E. faecalis.
Conclusions: The potent omadacycline activity observed in this study suggests potential clinical utility for treatment of bone/joint infections and rarely encountered Gram-positive infections caused by various staphylococci, streptococci, and enterococci isolates and supports ongoing clinical trials for these disease indications.
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Antimicrobial resistance among children in Southeast Asia: a systematic review.
Authors: Duguid RC et al
Abstract
Introduction: There is increasing evidence that antimicrobial resistance (AMR) is responsible for a large burden of morbidity and mortality in children, potentially compounded by reduced efficacy of many commonly recommended empirical antibiotic regimens to treat infections in children.
Methods: PRISMA framework was used to systematically review studies describing AMR in children (0 to 18 years) in Southeast Asia. Bacterial pathogens with a focus on the Global Antimicrobial Resistance Surveillance System (GLASS) reported in studies published between 2010 and 2023 were analyzed. For each pathogen, non-susceptibility to currently recommended WHO empirical antibiotics was analysed with descriptive statistics.
Results: AMR profiles for 21 191 bacterial isolates collated across 111 studies incorporating 484 540 children were evaluated. Most published data (71 studies) arose from India. High levels of non-susceptibility were evident in gram-negative pathogens, with Klebsiella spp. exhibiting particularly high levels of resistance to gentamicin (median: 64%; IQR 38 to 81, n=2097) and third-generation cephalosporins (median 76%; IQR 40 to 92, n=2415). Furthermore, a median of 73% (IQR 50 to 86, n=4405) of Escherichia coli isolates were non-susceptible to third-generation cephalosporins, and 48% (IQR 32 to 64, n=3659) were non-susceptible to gentamicin. Among gram-positive pathogens, the median methicillin resistance to Staphylococcus aureus was 43% (IQR 33 to 60, n=1139).
Conclusions: There are very high rates of AMR in pathogens isolated from children with common infectious illnesses in Southeast Asia. However, published data available are of variable quality and are heavily weighted towards South Asian countries (India, Nepal and Bangladesh), limiting the generalisability of these findings and highlighting the need for enhanced clinical surveillance networks to improve the surveillance within this populous and high-burden region.
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Knowledge, attitudes, practices and vaccine acceptance towards seasonal influenza vaccination among international travelers: a cross-sectional survey in Thailand
Authors: Pathomthep Leowattana
Abstract
Background: Influenza is a common but preventable disease. International travelers encounter significant risks in contracting influenza.
Methods: The cross-sectional, questionnaire-based study was conducted on international travelers while visiting the Thai Travel Clinic at Hospital for Tropical Diseases in Bangkok, Thailand.
Results: From May to November 2024, 250 Thai and 229 non-Thai international travelers were enrolled. Most participants reported sufficient knowledge about influenza, with 86.4% achieving a score of ≥ 60% while expressing mild concern of infection [mean perceived risk score of 3.1 ± 2.4 (range from 0-10)]. When regarding preventive measures, 77.2% reported regular hand hygiene, while only 19.4% regularly wore masks in public. Influenza vaccine acceptance was 38.6%. The most influential reason for vaccination was healthcare personnel’s advice. In the multivariable analysis, the independent factors which affected vaccine acceptance were travelers’ nationality, age, purpose of travel, destination country, and perceived risk score.
Conclusion: International travelers had sufficient influenza knowledge but low awareness relating to influenza prevention methods and influenza vaccinations. Low vaccine acceptance rates were observed among international travelers. Travel consultations should focus on influenza awareness while traveling and associated preventative measures.
Keywords: travelersinfluenzavaccine acceptanceKAP
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Clinical Pharmacokinetics and Safety of a New HIV-1 Capsid Inhibitor, VH4004280, After Oral Administration in Adults Without HIV
Authors: Nilay Thakkar
Abstract
Introduction: The pharmacokinetics, drug–drug interaction potential, and safety of a new HIV-1 capsid inhibitor, VH4004280 (VH-280), are described in this first-time-in-human study.
Methods: This randomized, double-blind, placebo-controlled, phase 1 study assessed oral VH-280 in adults without HIV. In parts 1 and 3, VH-280 was administered as powder-in-bottle (PiB) and tablet formulations, respectively, in single ascending doses. In part 2, VH-280 was administered as a PiB formulation once daily for 14 days in multiple ascending doses. In addition, in part 2, the effect of VH-280 on cytochrome P450 3A (CYP3A) activity was evaluated using midazolam as a probe substrate.
Results: In total, 73 participants were included (VH-280, n = 57; placebo, n = 16). Plasma exposures for VH-280 were broadly dose-proportional, and median time to maximum observed concentration was 9.0–17.0 h for the PiB and tablet formulations. Geometric mean terminal half-life was 145.8–207.8 h (> 6 days). Compared with PiB, exposures for the tablet formulation were 45–56% lower. Concomitant administration of midazolam after single and multiple doses of VH-280 did not result in clinically significant changes in midazolam or 1-hydroxymidazolam exposures; therefore, VH-280 is not anticipated to inhibit or induce CYP3A4. VH-280 was well-tolerated. Frequency of adverse events (AEs) was comparable between placebo and VH-280 groups. Adverse events related to VH-280 were primarily grade 1. There were no serious AEs, AEs leading to withdrawal from drug or study, or deaths. No trends in vital signs, electrocardiograms, or laboratory hematology parameters were observed, and there were no clinically relevant changes in chemistry parameters.
Conclusions: Data from this first-time-in-human study further characterize the pharmacokinetics of VH-280 after oral administration, providing support for the development of new capsid inhibitors as part of a complete long-acting regimen for the treatment and prevention of HIV-1.
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Respiratory Syncytial Virus (RSV) as a Secondary Diagnosis among Hospitalized Patients in Germany: Outcomes and Economic Burden
Authors: Weinert, M
Abstract
Introduction: Respiratory syncytial virus (RSV) is a pathogen that may cause severe respiratory infections. Recent research indicates that RSV may be underdiagnosed, especially in adult populations. This study aims to investigate the burden of RSV in hospitalized adults.
Methods: A retrospective, matched-control cohort study covering the seasons 2011/2012 to 2021/2022 was performed on the basis of anonymized claims data from 6 million individuals in multiple German statutory health funds. Analyses comprise hospitalized persons aged 18+ years. Patients with RSV were identified using the International Classification of Diseases, tenth revision, German Modification (ICD-10-GM) codes directly related to RSV (narrow approach) and indirectly related to RSV (ICD-10-GM codes covering lower respiratory tract infections, broad approach). Comparing these cohorts can provide a reasonable estimate of upper and lower bounds. For patients with a secondary inpatient diagnosis of RSV, we evaluated mortality rates, lengths of stay (LOS), costs, special fees, intensive care unit (ICU) admission rates, ventilation rates, and use of high-flow oxygen. Cohorts were matched with controls using an 1:1 exact matching approach using age, sex, Charlson Comorbidity Index (CCI, excluding age), main inpatient diagnosis, and quarter/year of admission.
Results: Mortality rates were between 15.5 (standard deviation, SD 1.031) and 19.8 (SD 0.070) times higher for patients with secondary inpatient diagnosis of RSV compared with their controls. Average LOS was 1.77 (SD 0.007) times longer than in controls, and healthcare costs were between 5600 EUR (SD 132.81) and 8400 EUR (SD 2313.54) higher for patients with RSV. No significant differences were found between patients with RSV and controls with respect to rehospitalization rate, invasive ventilation rate, or high-flow oxygen rate; however, patients indirectly related to RSV were admitted more often to intensive care (10.54% versus 3.25%).
Conclusions: Our study provides a deeper understanding of how RSV secondary diagnosis affects hospitalized patients, finding that RSV infection dramatically increases mortality rate, LOS, and inpatient healthcare costs. These findings support a broad RSV-vaccination recommendation for this patient group.
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Predicting ICU Admission Risk in Children with Respiratory Syncytial Virus
Authors: Lee, Y.H
Abstract
Introduction: Respiratory syncytial virus (RSV) is a common infection in young children and a frequent cause of hospitalization. In some cases, RSV can lead to severe lower respiratory tract illness requiring admission to the intensive care unit (ICU). Here, we explore risk factors for RSV-related ICU admission in children.
Methods: We conducted a retrospective study using Electronic Medical Record (EMR) data transformed into the Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM) from three tertiary care centers in Korea between 2008 and 2022. We identified 1529 children hospitalized with RSV according to the CDM and examined risk factors for ICU admission in this population.
Results: Of 33,674 children aged 0–9 years who tested for RSV, 1529 (4.5%) were positive. The highest proportion of RSV-positive children were less than 10 months old. The ICU admission rate among RSV-positive children was 1.8% (29/1529), and the highest ICU admission rate occurred in children aged 0–5 months (4.4%). In a multivariable logistic regression model, we found that the odds of ICU admission were higher in younger age groups, with the highest odds of ICU admission occurring in children aged 0–5 months (aOR 10.39, 95% CI 2.33–46.29). We also found that gestational age less than 27 weeks was associated with a 71-fold increased odds of ICU admission (aOR 71.64, 95% CI 4.64–1106.50) and that extremely low birth weight was associated with a 31-fold increase in odds of ICU admission (aOR 31.16, 95% CI 2.35–414.00).
Conclusions: We used the OMOP-CDM to identify risk factors for severe RSV infection requiring ICU admission in children. We found that young age, low gestational age, and low birth weight were associated with increased odds of ICU admission. Further research is needed to validate our findings and to examine other potential risk factors for severe RSV infection.