Pub Date : 2025-12-10DOI: 10.1016/j.lanmic.2025.101262
Giorgia Gon, Sokvy Ma, Alexander M Aiken, Stephanie J Dancer, Wendy J Graham, Stephen Nash, Vandarith Nov, Sovathiro Mao, Bernice Sarpong, Maxine Pepper, Sreytouch Vong, Vouchnea Tang, Jennifer Thompson, Ir Por
Background: Cleanliness of near-patient hospital surfaces is essential for preventing health care-associated infections and the spread of antimicrobial-resistant pathogens. Randomised evaluations of cleaning interventions have not been done in low-resource settings. We assessed the effectiveness of a hospital-based training intervention (Clean Frontline) to improve the microbiological cleanliness of near-patient surfaces.
Methods: In this stepped-wedge, cluster-randomised trial in 13 Cambodian referral hospitals, we defined four steps (timings) that define the transition from control to intervention. All eligible public referral hospitals (district or provincial) in three selected provinces consented to participate. Pre-intervention, environmental cleaning practices remained unchanged. The multicomponent intervention selected, trained, and supervised facility cleaning champions, who in turn trained and supervised hospital cleaners. The primary outcome was microbiological cleanliness of near-patient surfaces, assessed using dipslides (a surface with <2·5 colony-forming units per cm2 was classified as clean). 30 samples per hospital were collected monthly over 10 months. Outcome data collection and analysis teams were masked to treatment allocation. The primary outcome was estimated at surface level (primary analysis, odds ratio) and hospital level (risk difference), using an intention-to-treat approach and adjusted for a-priori confounders: temperature, patient numbers, beds per cleaner, and surface type. This trial is registered with ClinicalTrials.gov, NCT05540886, and is complete.
Findings: Across the 13 participating hospitals, a total of 53 champions and 51 cleaners were trained. Outcomes were measured monthly between May 3, 2022, and March 23, 2023. We collected 3900 samples, 3822 of which were used in the analyses. We observed a positive, although non-significant, effect of the intervention on cleanliness in the surface analysis (odds ratio 1·39 [95% CI 0·95-2·03], p=0·081). The hospital-level analysis indicated a significant improvement of 5·04 percentage points (95% CI 0·76-9·33, p=0·026).
Interpretation: Improving microbiological cleanliness of near-patient surfaces in hospitals in low-resource settings through the delivery of context-appropriate training and support is feasible. Further research should test this intervention with a wider number of clusters. Lessons learnt from the implementation will inform WHO roll-out of the training package.
Funding: Who Gives A Crap and the Reckitt Global Hygiene Institute.
背景：医院近病人表面的清洁对于预防卫生保健相关感染和耐药病原体的传播至关重要。在资源匮乏的环境中，尚未对清洁干预措施进行随机评估。我们评估了以医院为基础的培训干预（清洁前线）的有效性，以提高患者附近表面的微生物清洁度。方法：在13家柬埔寨转诊医院进行的这一楔形分步、聚类随机试验中，我们定义了四个步骤（时间）来定义从控制到干预的过渡。在选定的三个省，所有符合条件的公立转诊医院（区或省）都同意参与。干预前的环境清洁做法保持不变。多组分干预选择，培训和监督设施清洁冠军，他们反过来培训和监督医院清洁工。主要结果是用蘸片评估患者附近表面的微生物清洁度（2级表面为清洁）。每家医院在10个月内每月采集30份样本。结果数据收集和分析小组对治疗分配不知情。主要结局在表面水平（主要分析，优势比）和医院水平（风险差异）进行估计，使用意向治疗方法，并根据先验混杂因素进行调整：温度、患者数量、每个清洁工的床位和表面类型。该试验已在ClinicalTrials.gov注册，编号NCT05540886，并且已经完成。结果：在13家参与医院中，共有53名冠军和51名清洁工接受了培训。结果在2022年5月3日至2023年3月23日期间每月测量一次。我们收集了3900个样本，其中3822个用于分析。在表面分析中，我们观察到干预对清洁度的积极影响，尽管不显著（优势比1.39 [95% CI 0.95 - 2.03], p= 0.081）。医院水平分析显示，显著改善5.04个百分点（95% CI 0.76 - 9.33, p= 0.026）。解释：在资源匮乏的环境中，通过提供适合环境的培训和支持，改善医院近病人表面的微生物清洁度是可行的。进一步的研究应该在更广泛的群体中检验这种干预措施。从实施中吸取的经验教训将为世卫组织推出一揽子培训提供参考。资助：Who Gives A Crap和利洁时全球卫生研究所。
{"title":"Impact of a multicomponent training intervention (Clean FrontLine) on microbiological cleanliness in Cambodian referral hospitals: a multicentre, stepped-wedge, cluster-randomised trial.","authors":"Giorgia Gon, Sokvy Ma, Alexander M Aiken, Stephanie J Dancer, Wendy J Graham, Stephen Nash, Vandarith Nov, Sovathiro Mao, Bernice Sarpong, Maxine Pepper, Sreytouch Vong, Vouchnea Tang, Jennifer Thompson, Ir Por","doi":"10.1016/j.lanmic.2025.101262","DOIUrl":"https://doi.org/10.1016/j.lanmic.2025.101262","url":null,"abstract":"<p><strong>Background: </strong>Cleanliness of near-patient hospital surfaces is essential for preventing health care-associated infections and the spread of antimicrobial-resistant pathogens. Randomised evaluations of cleaning interventions have not been done in low-resource settings. We assessed the effectiveness of a hospital-based training intervention (Clean Frontline) to improve the microbiological cleanliness of near-patient surfaces.</p><p><strong>Methods: </strong>In this stepped-wedge, cluster-randomised trial in 13 Cambodian referral hospitals, we defined four steps (timings) that define the transition from control to intervention. All eligible public referral hospitals (district or provincial) in three selected provinces consented to participate. Pre-intervention, environmental cleaning practices remained unchanged. The multicomponent intervention selected, trained, and supervised facility cleaning champions, who in turn trained and supervised hospital cleaners. The primary outcome was microbiological cleanliness of near-patient surfaces, assessed using dipslides (a surface with <2·5 colony-forming units per cm<sup>2</sup> was classified as clean). 30 samples per hospital were collected monthly over 10 months. Outcome data collection and analysis teams were masked to treatment allocation. The primary outcome was estimated at surface level (primary analysis, odds ratio) and hospital level (risk difference), using an intention-to-treat approach and adjusted for a-priori confounders: temperature, patient numbers, beds per cleaner, and surface type. This trial is registered with ClinicalTrials.gov, NCT05540886, and is complete.</p><p><strong>Findings: </strong>Across the 13 participating hospitals, a total of 53 champions and 51 cleaners were trained. Outcomes were measured monthly between May 3, 2022, and March 23, 2023. We collected 3900 samples, 3822 of which were used in the analyses. We observed a positive, although non-significant, effect of the intervention on cleanliness in the surface analysis (odds ratio 1·39 [95% CI 0·95-2·03], p=0·081). The hospital-level analysis indicated a significant improvement of 5·04 percentage points (95% CI 0·76-9·33, p=0·026).</p><p><strong>Interpretation: </strong>Improving microbiological cleanliness of near-patient surfaces in hospitals in low-resource settings through the delivery of context-appropriate training and support is feasible. Further research should test this intervention with a wider number of clusters. Lessons learnt from the implementation will inform WHO roll-out of the training package.</p><p><strong>Funding: </strong>Who Gives A Crap and the Reckitt Global Hygiene Institute.</p>","PeriodicalId":46633,"journal":{"name":"Lancet Microbe","volume":" ","pages":"101262"},"PeriodicalIF":20.4,"publicationDate":"2025-12-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145752316","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-02DOI: 10.1016/j.lanmic.2025.101292
Christoph Buchta, Stephan W Aberle, Stéphanie Albarède, Xavier Albe, Tony Badrick, Andreas Bietenbeck, Vincent Delatour, Gro Gidske, Andrea Griesmacher, Jaap J van Hellemond, Gitte M Henriksen, Jim F Huggett, István Juhos, Martin Kammel, Piet Meijer, Ingo Schellenberg, Heinz Zeichhardt, Cas Weykamp
In this Personal View, we introduce the concept of external quality assessment (EQA) super challenges, in which multiple EQA providers, at approximately the same time and in a coordinated manner, use test samples with identical characteristics in their programmes. The evaluation of test results from the resulting increase in the number of laboratories and test systems used (considering the resulting greater variety of influencing factors that apply to the analysis in the individual laboratories) enables the collection of data that reveals differences, advantages, and disadvantages of individual test systems, in addition to the extent of individual influencing factors. By comparing the analytical performance of test systems and highlighting their limitations, EQA super challenges and the examination results collected by them are valuable contributions for post-market surveillance of diagnostic tests, aid harmonisation in laboratory medicine, and help to identify areas for improvement for manufacturers, policy makers, and regulators. Especially during or in preparation for epidemics or pandemics, EQA super challenges are particularly valuable for public health institutions to quickly gain a clear picture of the testing performance.
{"title":"The concept of external quality assessment super challenges with special consideration of their importance during pandemics.","authors":"Christoph Buchta, Stephan W Aberle, Stéphanie Albarède, Xavier Albe, Tony Badrick, Andreas Bietenbeck, Vincent Delatour, Gro Gidske, Andrea Griesmacher, Jaap J van Hellemond, Gitte M Henriksen, Jim F Huggett, István Juhos, Martin Kammel, Piet Meijer, Ingo Schellenberg, Heinz Zeichhardt, Cas Weykamp","doi":"10.1016/j.lanmic.2025.101292","DOIUrl":"https://doi.org/10.1016/j.lanmic.2025.101292","url":null,"abstract":"<p><p>In this Personal View, we introduce the concept of external quality assessment (EQA) super challenges, in which multiple EQA providers, at approximately the same time and in a coordinated manner, use test samples with identical characteristics in their programmes. The evaluation of test results from the resulting increase in the number of laboratories and test systems used (considering the resulting greater variety of influencing factors that apply to the analysis in the individual laboratories) enables the collection of data that reveals differences, advantages, and disadvantages of individual test systems, in addition to the extent of individual influencing factors. By comparing the analytical performance of test systems and highlighting their limitations, EQA super challenges and the examination results collected by them are valuable contributions for post-market surveillance of diagnostic tests, aid harmonisation in laboratory medicine, and help to identify areas for improvement for manufacturers, policy makers, and regulators. Especially during or in preparation for epidemics or pandemics, EQA super challenges are particularly valuable for public health institutions to quickly gain a clear picture of the testing performance.</p>","PeriodicalId":46633,"journal":{"name":"Lancet Microbe","volume":" ","pages":"101292"},"PeriodicalIF":20.4,"publicationDate":"2025-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145688472","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01DOI: 10.1016/j.lanmic.2025.101226
Eskild Petersen , Giuseppe Ippolito , Markus Maeurer , Francine Ntoumi , Jean B Nachega , David S Hui , Alimuddin Zumla
{"title":"Protecting the future of vaccine development amidst US funding withdrawal for mRNA vaccine research","authors":"Eskild Petersen , Giuseppe Ippolito , Markus Maeurer , Francine Ntoumi , Jean B Nachega , David S Hui , Alimuddin Zumla","doi":"10.1016/j.lanmic.2025.101226","DOIUrl":"10.1016/j.lanmic.2025.101226","url":null,"abstract":"","PeriodicalId":46633,"journal":{"name":"Lancet Microbe","volume":"6 12","pages":"Article 101226"},"PeriodicalIF":20.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145006684","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01DOI: 10.1016/j.lanmic.2025.101234
Xinyu Wang , Xinyi Jiao , Ruihua Dong , Xiaoling Li , Di Wang , Zhiwen Jiang , Mei Kang , Andres Merits , Hao Li , Longxian Zhang , Zhihang Peng , Na He , Shuo Su
{"title":"Tick-borne viruses: moving the dial on diagnostics with diverse technological advances","authors":"Xinyu Wang , Xinyi Jiao , Ruihua Dong , Xiaoling Li , Di Wang , Zhiwen Jiang , Mei Kang , Andres Merits , Hao Li , Longxian Zhang , Zhihang Peng , Na He , Shuo Su","doi":"10.1016/j.lanmic.2025.101234","DOIUrl":"10.1016/j.lanmic.2025.101234","url":null,"abstract":"","PeriodicalId":46633,"journal":{"name":"Lancet Microbe","volume":"6 12","pages":"Article 101234"},"PeriodicalIF":20.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145066024","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01DOI: 10.1016/j.lanmic.2025.101244
Paige Fletcher PhD , Kyle L O’Donnell PhD , Friederike Feldmann ASS , Joseph F Rhoderick BSc , Chad S Clancy DVM PhD , Jil A Haase PhD , Cecilia A Prator PhD , Brian J Smith DVM , Bronwyn M Gunn PhD , Heinz Feldmann MD , Andrea Marzi PhD
Background
The Sudan virus (SUDV) outbreaks in recent years, including the most recent outbreak in Uganda, created a public health emergency in the eastern Africa region. There are no licensed vaccines or therapeutics approved against SUDV; however, we have previously developed a vesicular stomatitis virus (VSV)-based vaccine expressing the SUDV glycoprotein and showed its single-dose efficacy in non-human primates (NHPs) with pre-existing Ebola virus (EBOV) immunity. Here, we determined the fast-acting capacity of this vaccine in naive NHPs. In addition, we examined if the licensed VSV-EBOV vaccine would provide any prophylactic benefit against SUDV infection.
Methods
We used four groups of male cynomolgus macaques (n=6 per group) aged 2·5–4·5 years and weighing 2·9–5·2 kg. NHPs were vaccinated by intramuscular injection 28 days before challenge with either 1 × 107 plaque-forming units (PFUs) VSV-SUDV, VSV-EBOV, or control vaccine (VSV-LASV). Another group was vaccinated with 1 × 107 PFU VSV-SUDV 7 days before challenge. On day 0, all 24 NHPs were challenged with a lethal dose of SUDV (1 × 104 50% tissue culture infectious doses [TCID50] SUDV-Gulu, backtitred as 1·1 × 104 TCID50). We assessed anaesthetised NHPs on days –28, –21, –14, and –7 before challenge; days 0, 3, 6, 9, 14, 21, 28, and 35 after challenge; and at euthanasia (day 42 for survivors).
Findings
All VSV-SUDV-vaccinated NHPs were protected from disease after the lethal SUDV challenge. In contrast, the VSV-EBOV-vaccinated and control NHPs succumbed to disease between days 5 and 7 after challenge presenting with classical signs of Sudan virus disease associated with high-titre viraemia (>1 × 108 TCID50 per mL), high viral organ load (>1 × 108 TCID50 per g), dysregulated cytokine profiles, and typical pathological changes. The humoral immune response in the NHPs vaccinated with VSV-SUDV 1 month before challenge resulted in a profound and sustained serum antibody response (20 000–30 000 U/mL) with a diverse functionality profile (antibody-dependent cellular phagocytosis and antibody-dependent complement), which was not observed to the same extent in NHPs vaccinated 1 week before challenge.
Interpretation
We showed that a single dose of VSV-SUDV protected NHPs from lethal SUDV infection within 1 week. The fast-acting nature highlights VSV-SUDV as an ideal countermeasure for ring vaccination during outbreaks of Sudan virus disease pending further preclinical and clinical assessment. In contrast, VSV-EBOV provided no relevant protection against SUDV infection in NHPs, highlighting the need for species-specific filovirus vaccines.
Funding
National Institutes of Health, US Department of Health and Human Services.
{"title":"Fast-acting single-dose vesicular stomatitis virus-Sudan virus vaccine: a challenge study in macaques","authors":"Paige Fletcher PhD , Kyle L O’Donnell PhD , Friederike Feldmann ASS , Joseph F Rhoderick BSc , Chad S Clancy DVM PhD , Jil A Haase PhD , Cecilia A Prator PhD , Brian J Smith DVM , Bronwyn M Gunn PhD , Heinz Feldmann MD , Andrea Marzi PhD","doi":"10.1016/j.lanmic.2025.101244","DOIUrl":"10.1016/j.lanmic.2025.101244","url":null,"abstract":"<div><h3>Background</h3><div>The Sudan virus (SUDV) outbreaks in recent years, including the most recent outbreak in Uganda, created a public health emergency in the eastern Africa region. There are no licensed vaccines or therapeutics approved against SUDV; however, we have previously developed a vesicular stomatitis virus (VSV)-based vaccine expressing the SUDV glycoprotein and showed its single-dose efficacy in non-human primates (NHPs) with pre-existing Ebola virus (EBOV) immunity. Here, we determined the fast-acting capacity of this vaccine in naive NHPs. In addition, we examined if the licensed VSV-EBOV vaccine would provide any prophylactic benefit against SUDV infection.</div></div><div><h3>Methods</h3><div>We used four groups of male cynomolgus macaques (n=6 per group) aged 2·5–4·5 years and weighing 2·9–5·2 kg. NHPs were vaccinated by intramuscular injection 28 days before challenge with either 1 × 10<sup>7</sup> plaque-forming units (PFUs) VSV-SUDV, VSV-EBOV, or control vaccine (VSV-LASV). Another group was vaccinated with 1 × 10<sup>7</sup> PFU VSV-SUDV 7 days before challenge. On day 0, all 24 NHPs were challenged with a lethal dose of SUDV (1 × 10<sup>4</sup> 50% tissue culture infectious doses [TCID<sub>50</sub>] SUDV-Gulu, backtitred as 1·1 × 10<sup>4</sup> TCID<sub>50</sub>). We assessed anaesthetised NHPs on days –28, –21, –14, and –7 before challenge; days 0, 3, 6, 9, 14, 21, 28, and 35 after challenge; and at euthanasia (day 42 for survivors).</div></div><div><h3>Findings</h3><div>All VSV-SUDV-vaccinated NHPs were protected from disease after the lethal SUDV challenge. In contrast, the VSV-EBOV-vaccinated and control NHPs succumbed to disease between days 5 and 7 after challenge presenting with classical signs of Sudan virus disease associated with high-titre viraemia (>1 × 10<sup>8</sup> TCID<sub>50</sub> per mL), high viral organ load (>1 × 10<sup>8</sup> TCID<sub>50</sub> per g), dysregulated cytokine profiles, and typical pathological changes. The humoral immune response in the NHPs vaccinated with VSV-SUDV 1 month before challenge resulted in a profound and sustained serum antibody response (20 000–30 000 U/mL) with a diverse functionality profile (antibody-dependent cellular phagocytosis and antibody-dependent complement), which was not observed to the same extent in NHPs vaccinated 1 week before challenge.</div></div><div><h3>Interpretation</h3><div>We showed that a single dose of VSV-SUDV protected NHPs from lethal SUDV infection within 1 week. The fast-acting nature highlights VSV-SUDV as an ideal countermeasure for ring vaccination during outbreaks of Sudan virus disease pending further preclinical and clinical assessment. In contrast, VSV-EBOV provided no relevant protection against SUDV infection in NHPs, highlighting the need for species-specific filovirus vaccines.</div></div><div><h3>Funding</h3><div>National Institutes of Health, US Department of Health and Human Services.</div></div>","PeriodicalId":46633,"journal":{"name":"Lancet Microbe","volume":"6 12","pages":"Article 101244"},"PeriodicalIF":20.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145757985","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01DOI: 10.1016/j.lanmic.2025.101237
Emily A Kendall MD , Prof Claudia M Denkinger MD , Prof Adithya Cattamanchi MD , Prof David W Dowdy MD , Prof Jason R Andrews MD
Tuberculosis encompasses a spectrum of characteristics—including bacillary burden, clinical severity, and access to care—that are relevant to clinical and epidemiological outcomes and the performance of diagnostic assays. The value of diagnostic assays depends not only on their numerical accuracy, which can vary substantially between populations, but also on which individuals with and without tuberculosis the assays identify. Moreover, detectable features of tuberculosis, such as pathogen burden or host responses, are often correlated, making it difficult to predict the accuracy and impact of diagnostic algorithms from the accuracies of individual component tests. Therefore, when evaluating novel tuberculosis diagnostics, greater consideration should be given to characterising which segments of the disease spectrum are detected, how these segments overlap across tests, and how they are prioritised for detection. Understanding these relationships is particularly crucial for screening, given that screening seeks to detect a broad spectrum of disease and often uses multistep algorithms. We present a framework for understanding the sensitivity and specificity of assays and algorithms as the degree of alignment between different subsets of the disease spectrum. Based on this framework, we make recommendations for the measurement, reporting, target setting, and interpretation of diagnostic accuracy to guide both novel test development and the optimal use of existing diagnostics.
{"title":"Whom tuberculosis tests detect and why it matters: implications for diagnostic algorithms","authors":"Emily A Kendall MD , Prof Claudia M Denkinger MD , Prof Adithya Cattamanchi MD , Prof David W Dowdy MD , Prof Jason R Andrews MD","doi":"10.1016/j.lanmic.2025.101237","DOIUrl":"10.1016/j.lanmic.2025.101237","url":null,"abstract":"<div><div>Tuberculosis encompasses a spectrum of characteristics—including bacillary burden, clinical severity, and access to care—that are relevant to clinical and epidemiological outcomes and the performance of diagnostic assays. The value of diagnostic assays depends not only on their numerical accuracy, which can vary substantially between populations, but also on which individuals with and without tuberculosis the assays identify. Moreover, detectable features of tuberculosis, such as pathogen burden or host responses, are often correlated, making it difficult to predict the accuracy and impact of diagnostic algorithms from the accuracies of individual component tests. Therefore, when evaluating novel tuberculosis diagnostics, greater consideration should be given to characterising which segments of the disease spectrum are detected, how these segments overlap across tests, and how they are prioritised for detection. Understanding these relationships is particularly crucial for screening, given that screening seeks to detect a broad spectrum of disease and often uses multistep algorithms. We present a framework for understanding the sensitivity and specificity of assays and algorithms as the degree of alignment between different subsets of the disease spectrum. Based on this framework, we make recommendations for the measurement, reporting, target setting, and interpretation of diagnostic accuracy to guide both novel test development and the optimal use of existing diagnostics.</div></div>","PeriodicalId":46633,"journal":{"name":"Lancet Microbe","volume":"6 12","pages":"Article 101237"},"PeriodicalIF":20.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145337784","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01DOI: 10.1016/j.lanmic.2025.101246
Manjulika Das
{"title":"Suriname: first malaria-free country in the Amazon region","authors":"Manjulika Das","doi":"10.1016/j.lanmic.2025.101246","DOIUrl":"10.1016/j.lanmic.2025.101246","url":null,"abstract":"","PeriodicalId":46633,"journal":{"name":"Lancet Microbe","volume":"6 12","pages":"Article 101246"},"PeriodicalIF":20.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145179398","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01DOI: 10.1016/j.lanmic.2025.101189
Joanna Furnival-Adams PhD , Amelia Houana MD , Francisco Saute PhD , Eldo Elobolobo MSc , Matthew Rudd PhD , Patricia Nicolas MSc , Julia Montaña MSc , Samuel Martinho MPH , Hansel Mundaca MSc , Jenisse Mbanze MSc , Arlindo Soares BSc , Saimado Imputiua BSc , Paula Ruiz-Castillo PhD , Marta Ribes PhD , Almudena Sanz MSc , Mussa Mamudo Salé PhD , Antonio Macucha MD , Aina Casellas MSc , Valeria Lopez MD , Vegovito Vegove BSc , Carlos Chaccour PhD
<div><h3>Background</h3><div>Ivermectin is an endectocide effective against scabies that is under evaluation as a malaria vector control tool. During the BOHEMIA malaria trial, we did a substudy with the aim of assessing the efficacy of ivermectin mass drug administration (MDA) against scabies.</div></div><div><h3>Methods</h3><div>The BOHEMIA trial was an open-label, assessor-masked, cluster-randomised trial done in a malaria and scabies co-endemic community in Mozambique. Clusters were randomised (1:1:1) to receive a single dose of either ivermectin 400 μg/kg to all eligible humans, 400 μg/kg to humans and 200 μg/kg to eligible livestock, or 400 mg albendazole in humans only (control) for 3 consecutive months. In this scabies substudy, 39 clusters were randomly selected from the main trial. The primary endpoint was scabies prevalence at 3 months. Secondary endpoints were scabies prevalence in directly exposed participants (those who took the study drug) at 1, 2, and 3 months, and indirectly exposed children younger than 5 years (who were living in clusters but did not take the study drug) at 3 and 6 months. An intention-to-treat analysis was done by use of a logistic regression model with a generalised estimating equation approach. This study is registered with <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span>, <span><span>NCT04966702</span><svg><path></path></svg></span>, and on the Pan African Clinical Trial Registry, PACTR202106695877303, and is complete.</div></div><div><h3>Findings</h3><div>Recruitment started on March 15, 2022 and was completed on July 6, 2022. Of 40 524 participants from 100 clusters accessed in the BOHEMIA trial, 1951 participants were enrolled from 39 clusters (13 per group) in the scabies substudy. Scabies prevalence in the ivermectin group was lower after 3 months (2·11%, 95% CI 1·21–3·41) than at baseline (8·10%, 6·36–9·85), whereas it did not change in the albendazole group (13·71%, 10·81–17·05, at 3 months <em>vs</em> 12·30%, 9·43–15·17, at baseline). The odds of having scabies was lower in pooled ivermectin clusters than in albendazole clusters after 3 months (adjusted odds ratio [aOR] 0·18, 95% CI 0·07–0·45, p=0·0002). This effect was observed both in directly exposed participants who took ivermectin after 1 month (aOR 0·27, 95% CI 0·11–0·66, p=0·0023), 2 months (0·18, 0·07–0·47, p=0·0006), and 3 months (0·16, 0·06–0·45, p=0·0004), and in indirectly exposed children after 3 months (0·17, 0·05–0·58, p=0·0048) and 6 months (0·21, 0·06–0·72, p=0·013). There were two severe adverse events; both were deaths in the ivermectin group that were not considered related to the study drug. No safety signal was detected.</div></div><div><h3>Interpretation</h3><div>Ivermectin MDA designed for malaria might have significant benefits against scabies. In addition to directly exposed participants, our results also suggested an effect in indirectly exposed participants, which might reflect a community benefit.</di
{"title":"Direct and indirect protection against scabies through ivermectin mass drug administration designed for malaria in Mozambique: a substudy nested within a cluster-randomised, controlled trial","authors":"Joanna Furnival-Adams PhD , Amelia Houana MD , Francisco Saute PhD , Eldo Elobolobo MSc , Matthew Rudd PhD , Patricia Nicolas MSc , Julia Montaña MSc , Samuel Martinho MPH , Hansel Mundaca MSc , Jenisse Mbanze MSc , Arlindo Soares BSc , Saimado Imputiua BSc , Paula Ruiz-Castillo PhD , Marta Ribes PhD , Almudena Sanz MSc , Mussa Mamudo Salé PhD , Antonio Macucha MD , Aina Casellas MSc , Valeria Lopez MD , Vegovito Vegove BSc , Carlos Chaccour PhD","doi":"10.1016/j.lanmic.2025.101189","DOIUrl":"10.1016/j.lanmic.2025.101189","url":null,"abstract":"<div><h3>Background</h3><div>Ivermectin is an endectocide effective against scabies that is under evaluation as a malaria vector control tool. During the BOHEMIA malaria trial, we did a substudy with the aim of assessing the efficacy of ivermectin mass drug administration (MDA) against scabies.</div></div><div><h3>Methods</h3><div>The BOHEMIA trial was an open-label, assessor-masked, cluster-randomised trial done in a malaria and scabies co-endemic community in Mozambique. Clusters were randomised (1:1:1) to receive a single dose of either ivermectin 400 μg/kg to all eligible humans, 400 μg/kg to humans and 200 μg/kg to eligible livestock, or 400 mg albendazole in humans only (control) for 3 consecutive months. In this scabies substudy, 39 clusters were randomly selected from the main trial. The primary endpoint was scabies prevalence at 3 months. Secondary endpoints were scabies prevalence in directly exposed participants (those who took the study drug) at 1, 2, and 3 months, and indirectly exposed children younger than 5 years (who were living in clusters but did not take the study drug) at 3 and 6 months. An intention-to-treat analysis was done by use of a logistic regression model with a generalised estimating equation approach. This study is registered with <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span>, <span><span>NCT04966702</span><svg><path></path></svg></span>, and on the Pan African Clinical Trial Registry, PACTR202106695877303, and is complete.</div></div><div><h3>Findings</h3><div>Recruitment started on March 15, 2022 and was completed on July 6, 2022. Of 40 524 participants from 100 clusters accessed in the BOHEMIA trial, 1951 participants were enrolled from 39 clusters (13 per group) in the scabies substudy. Scabies prevalence in the ivermectin group was lower after 3 months (2·11%, 95% CI 1·21–3·41) than at baseline (8·10%, 6·36–9·85), whereas it did not change in the albendazole group (13·71%, 10·81–17·05, at 3 months <em>vs</em> 12·30%, 9·43–15·17, at baseline). The odds of having scabies was lower in pooled ivermectin clusters than in albendazole clusters after 3 months (adjusted odds ratio [aOR] 0·18, 95% CI 0·07–0·45, p=0·0002). This effect was observed both in directly exposed participants who took ivermectin after 1 month (aOR 0·27, 95% CI 0·11–0·66, p=0·0023), 2 months (0·18, 0·07–0·47, p=0·0006), and 3 months (0·16, 0·06–0·45, p=0·0004), and in indirectly exposed children after 3 months (0·17, 0·05–0·58, p=0·0048) and 6 months (0·21, 0·06–0·72, p=0·013). There were two severe adverse events; both were deaths in the ivermectin group that were not considered related to the study drug. No safety signal was detected.</div></div><div><h3>Interpretation</h3><div>Ivermectin MDA designed for malaria might have significant benefits against scabies. In addition to directly exposed participants, our results also suggested an effect in indirectly exposed participants, which might reflect a community benefit.</di","PeriodicalId":46633,"journal":{"name":"Lancet Microbe","volume":"6 12","pages":"Article 101189"},"PeriodicalIF":20.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145582558","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
扫码关注我们
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号