Clinical Microbiology and Infection最新文献

{"title":"Reporting of sociodemographic characteristics of trial participants in infectious diseases clinical trials-a systematic review.","authors":"Sean W X Ong, Christina Blagojevic, Aliya Bryce, Aaron Ovadia, Matthew Slater, Daire Pryal, Rodrigo Escobar Careaga, Hadrien Moffroid, Arvind Yerramilli, Esmita Charani, Nick Daneman, Steven Y C Tong","doi":"10.1016/j.cmi.2025.04.030","DOIUrl":"10.1016/j.cmi.2025.04.030","url":null,"abstract":"<p><strong>Background: </strong>Reporting of demographic characteristics in randomized clinical trials (RCTs) is recommended to facilitate assessment of generalizability to other populations. However, there is a lack of consensus as to what variables should be reported, and there are limited data describing current research practice.</p><p><strong>Objectives: </strong>We aimed to evaluate reporting of sociodemographic characteristics of participants in infectious diseases RCTs and identify gaps in current practice.</p><p><strong>Methods: </strong>We conducted a systematic review of all infectious diseases-related RCTs published between January 2014 and August 2023 in ten selected high-impact journals by searching the Ovid MEDLINE database. Outcomes of interest were the reporting of five patient-level sociodemographic characteristics, as recommended by the CONSORT-Equity 2017 extension to the CONSORT (Consolidated Standards of Reporting Trials) reporting guidelines: (a) ethnicity, (b) sex and/or gender, (c) education level, (d) socioeconomic status (SES), and (e) rurality. We summarized descriptive results for the reporting of each characteristic overall, by trial type (health equity-related vs. non-health equity-related), subject area, and year of publication. We fitted multivariable logistic regression models to identify trial characteristics associated with the reporting of each characteristic. Risk of bias of trials was not assessed as our objective was to assess trial reporting and not results.</p><p><strong>Results: </strong>We screened 4234 articles and included 1343. Almost all trials (1201/1233, 97.4%) reported sex and/or gender. In contrast, less than half (654/1326, 49.3%) reported ethnicity, and only a minority reported education level (113/1252, 9.0%), SES (120/1340, 9.0%), and rurality (45/1269, 3.9%). There was no improvement in reporting of each characteristic over the 10-year period. Subject area, funding source, whether a trial was health equity-related, use of a medical writer, and trial setting (high vs. low/middle-income country) were significantly associated with the reporting of ethnicity, education level, and SES.</p><p><strong>Conclusions: </strong>Reporting of sociodemographic characteristics in infectious diseases RCTs is inconsistent and has not improved over time.</p>","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":" ","pages":""},"PeriodicalIF":10.9,"publicationDate":"2025-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143961415","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Septic pubic symphysitis: newest radiological, microbiological, and outcome findings in a rare and difficult-to-treat infection.","authors":"Solène Tabary, François Robin, Christelle Darrieutort-Laffite, Florent Lautredoux, Pascal Guggenbuhl, Géraldine Bart","doi":"10.1016/j.cmi.2025.04.028","DOIUrl":"10.1016/j.cmi.2025.04.028","url":null,"abstract":"","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":" ","pages":""},"PeriodicalIF":10.9,"publicationDate":"2025-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143988047","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Stewardship recommendations at your fingertips: a smartphone application for hospital-based antibiotic decision-making","authors":"Katharina Rynkiewich ,&nbsp;Robin L.P. Jump","doi":"10.1016/j.cmi.2025.04.032","DOIUrl":"10.1016/j.cmi.2025.04.032","url":null,"abstract":"","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":"31 7","pages":"Pages 1100-1102"},"PeriodicalIF":10.9,"publicationDate":"2025-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143985363","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Uncovering hidden transmission pathways of Klebsiella pneumoniae: is there a need to re-evaluate the necessity for toilet disinfection?","authors":"Aila Caplunik-Pratsch, Livia Grancicova, Bärbel Kieninger, Anja Eichner, Wulf Schneider-Brachert, Anca Rath","doi":"10.1016/j.cmi.2025.04.033","DOIUrl":"10.1016/j.cmi.2025.04.033","url":null,"abstract":"","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":" ","pages":""},"PeriodicalIF":10.9,"publicationDate":"2025-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143957139","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"More questions than answers? Predicting faecal microbiota transplantation outcomes for recurrent Clostridioides difficile infection","authors":"Georgiana-Emmanuela Gîlcă-Blanariu ,&nbsp;Sepideh Pakpour ,&nbsp;Dina Kao","doi":"10.1016/j.cmi.2025.04.036","DOIUrl":"10.1016/j.cmi.2025.04.036","url":null,"abstract":"","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":"31 7","pages":"Pages 1095-1096"},"PeriodicalIF":10.9,"publicationDate":"2025-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143988952","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evidence of Coxiella burnetii and Bartonella species infections among patients with persistent febrile illness in four low- and middle-income countries.","authors":"Carl Boodman, Sophie Edouard, Johan van Griensven, Kanika Deshpande Koirala, Basudha Khanal, Suman Rijal, Narayan Raj Bhattarai, Sayda El Safi, Thong Phe, Kruy Lim, Pascal Lutumba, François Chappuis, Cédric P Yansouni, Barbara Barbé, Marjan van Esbroeck, Tine Verdonck, Marleen Boelaert, Pierre-Édouard Fournier, Emmanuel Bottieau","doi":"10.1016/j.cmi.2025.04.038","DOIUrl":"10.1016/j.cmi.2025.04.038","url":null,"abstract":"<p><strong>Objectives: </strong>This study investigated whether infections due to Coxiella burnetii, Bartonella species or Tropheryma whipplei could be identified among biobanked samples associated with persistent fever in four low- or middle-income countries.</p><p><strong>Methods: </strong>The NIDIAG consortium (\"Better DIAGnosis of Neglected Infectious Diseases\") prospectively investigated in 2013-2014 the aetiological spectrum of 1922 patients with persistent febrile illness (fever greater than 7 days) in Cambodia, Nepal, Sudan, and the Democratic Republic of Congo (DRC). Our study retrospectively tested serum and blood samples from the 745 patients (38.8%) who remained without an identified cause of fever. Indirect immunofluorescent antibody assays (IFA) were performed (except in the DRC) to assess immunoglobulin response to C. burnetii and Bartonella antigens. DNA extracts from whole blood samples were tested for C. burnetii, Bartonella genus, B. quintana, B. henselae and T. whipplei by qPCR.</p><p><strong>Results: </strong>Evidence of infection with C. burnetii or Bartonella sp. was found in 124 persistent fever cases (16.6%). IFA for IgG to C. burnetii phase I and II antigens identified 59 (7.9%) positive sera: 31/333 (9.3%) from Sudan, 16/278 (5.8%) from Nepal, and 12/54 (22.2%) from Cambodia. Eight individuals had C. burnetii anti-phase I IgG titres ≥ 1:800. Bartonella IFA identified 60 (8.1%) IgG positive sera, with 49/278 (17.6%) positive samples from Nepal, 7/333 (2.1%) from Sudan and 4/54 (7.4%) from Cambodia. One serum from Sudan had anti-Bartonella IgG titres of 1:800. C. burnetii DNA was detected from blood in 3 individuals from Sudan and one individual from the DRC, whereas B. quintana DNA was present in a blood sample from a Nepalese individual. All qPCR tests for T. whipplei were negative.</p><p><strong>Discussion: </strong>Direct and indirect evidence of C. burnetii or Bartonella sp. infections was observed in persistent fever cases. Further studies are necessary to elucidate the burden of these diseases in low- or middle-income countries.</p>","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":" ","pages":""},"PeriodicalIF":10.9,"publicationDate":"2025-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143977620","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Target trial emulation framework: mitigating methodological challenges and application in COVID-19 treatment evaluation studies.","authors":"Oksana Martinuka, Saskia le Cessie, Martin Wolkewitz","doi":"10.1016/j.cmi.2025.04.027","DOIUrl":"10.1016/j.cmi.2025.04.027","url":null,"abstract":"<p><strong>Background: </strong>During the COVID-19 pandemic, real-world data and observational studies played an important role in assessing treatment effectiveness. Methodological challenges such as confounding, immortal time bias, and competing risks were observed. Target trial emulation provides a structured framework for evaluating treatment effectiveness using observational data while mitigating these biases.</p><p><strong>Objectives: </strong>To describe common biases in observational COVID-19 research, introduce the target trial emulation framework, and discuss how these biases can be addressed in this framework. Specifically, we discuss the clone-censor-weight approach and provide real-world study examples demonstrating its application in COVID-19 research.</p><p><strong>Sources: </strong>We summarise key principles of target trial emulation and the clone-censor-weight approach using published methodological articles. Additionally, we demonstrate the practical implementation by reviewing three studies that emulated a target trial to evaluate the effects of treatments in patients with COVID-19. These studies were selected without a predefined search strategy.</p><p><strong>Content: </strong>We define and discuss confounding, immortal time bias, and competing risks in studies using observational data. To facilitate the understanding of these biases, we use a hypothetical example evaluating the effects of hydroxychloroquine in hospitalised patients with COVID-19. We provide an overview of the target trial emulation framework and its core elements, explaining how it can mitigate these challenges. To illustrate the clone-censor-weight approach, we describe published examples demonstrating its application during the COVID-19 pandemic.</p><p><strong>Implications: </strong>Target trial emulation is an important framework for evaluating treatment effects using observational data, but it requires careful implementation to mitigate methodological biases. Identifying and addressing confounding, immortal time bias, and competing risks during study design and analysis are important in any causal study evaluating treatment effects. This framework can improve the quality of observational studies and complement evidence from clinical trials, particularly when evidence is urgently needed, as during the first waves of the COVID-19 pandemic.</p>","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":" ","pages":""},"PeriodicalIF":10.9,"publicationDate":"2025-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143957157","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Target attainment of benzylpenicillin in patients with infective endocarditis.","authors":"Magnus Bock, Johan G C Van Hasselt, Kurt Fuursted, Nikolaj Ihlemann, Sabine Gill, Ulrik Christiansen, Niels Eske Bruun, Hanne Elming, Jonas A Povlsen, Lars Køber, Dan E Høfsten, Emil L Fosbøl, Mia M Pries-Heje, Jens Jørgen Christensen, Flemming S Rosenvinge, Christian Torp Pedersen, Jannik Helweg-Larsen, Niels Tønder, Kasper Iversen, Henning Bundgaard, Claus Moser","doi":"10.1016/j.cmi.2025.04.025","DOIUrl":"10.1016/j.cmi.2025.04.025","url":null,"abstract":"<p><strong>Objectives: </strong>Benzylpenicillin is commonly used to treat infective endocarditis, particularly for streptococcal infections. This study aimed to perform pharmacokinetic/pharmacodynamic analyses of benzylpenicillin to assess the probability of target attainment (PTA) across different pathogens, MIC values, pharmacokinetic/pharmacodynamic targets, and renal function levels.</p><p><strong>Methods: </strong>In the Partial Oral Endocarditis Treatment trial, patients with left-sided infective endocarditis were randomly assigned to either conventional intravenous or partial oral antibiotic treatment. This substudy included patients receiving intravenous benzylpenicillin (3000 mg q6h). Pharmacokinetic measurements were conducted, and a population pharmacokinetic model was developed to estimate PTAs through model-based simulations. Pharmacokinetic/pharmacodynamic targets were based on time above MIC (or 4 × MIC) of the free concentration (fT > MIC or fT > 4 × MIC).</p><p><strong>Results: </strong>A total of 75 patients were included, and 291 plasma concentrations were obtained. MIC values were available for 68 patients. Individual target attainment for 50% fT > MIC and 50% fT > 4 × MIC targets was 100% (56/56) and 94.6% (53/56) for streptococci, 100% (3/3) for staphylococci, but only 66.7% (6/9) and 33.3% (3/9) for Enterococcus faecalis. For more stringent targets of 100% fT > MIC and 100% fT > 4 × MIC, individual target attainment was 89.3% (50/56) and 75.0% (42/56) for streptococci, 100.0% (3/3) and 66.7% (2/3) for staphylococci, but 33.3% (3/9) and 11.1% (1/9) for E. faecalis. Simulations showed PTAs above 90% for MIC values ≤ 0.5 mg/L at the 50% fT > MIC target, and for MIC values ≤ 0.063 mg/L at 50% fT > 4 × MIC or 100% fT > MIC targets. Higher renal clearance was associated with substantially lower PTAs.</p><p><strong>Discussion: </strong>Intravenous benzylpenicillin achieved target levels in most patients with infective endocarditis, particularly for those infected with streptococci or susceptible staphylococci. However, low individual target attainment in patients with E. faecalis suggests limitations in treating enterococcal endocarditis, especially in patients with preserved renal function.</p>","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":" ","pages":""},"PeriodicalIF":10.9,"publicationDate":"2025-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144062565","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Which trial do we need? A randomised controlled study to compare the protective efficacy of early post-exposure discontinuation versus standard atovaquone-proguanil malaria prophylaxis in a human Plasmodium falciparum challenge model.","authors":"Jenny L Schnyder, Hanna K de Jong, Emmanuel B Bache, Reinier M van Hest, Sabine Bélard, Thomas Hanscheid, Peter G Kremsner, Martin P Grobusch","doi":"10.1016/j.cmi.2025.04.023","DOIUrl":"10.1016/j.cmi.2025.04.023","url":null,"abstract":"","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":" ","pages":""},"PeriodicalIF":10.9,"publicationDate":"2025-04-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143967984","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Long-term sequelae post-hospitalization for respiratory syncytial virus vs. Omicron SARS-CoV-2 or influenza in adults and children: a retrospective cohort study.","authors":"Liang En Wee, Reen Wan Li Ho, Jue Tao Lim, Calvin J Chiew, Barnaby Young, Chee-Fu Yung, Chia Yin Chong, David Chien Boon Lye, Kelvin Bryan Tan","doi":"10.1016/j.cmi.2025.04.022","DOIUrl":"10.1016/j.cmi.2025.04.022","url":null,"abstract":"<p><strong>Objectives: </strong>Risk of long-term sequelae after COVID-19 hospitalization is well documented in adults and children; however, less is known about long-term sequelae after hospitalization for other respiratory viral infections (RVIs), such as respiratory syncytial virus (RSV). We sought to compare long-term sequelae after RSV hospitalization, contrasted against Omicron COVID-19 and influenza, in children and adults.</p><p><strong>Methods: </strong>This retrospective population-based cohort study in Singapore included all hospitalizations for RSV/influenza from 1 January 2017 to 3 September 2023, and all COVID-19 hospitalizations after Omicron emergence (1 January 2022-3 September 2023). Risks of new-incident diagnoses/symptoms 31-300 days following (a) RSV vs. COVID-19 hospitalization; (b) RSV vs. influenza hospitalization, across multiple organ systems, were estimated using Cox regression, adjusted for between-group sociodemographic and clinical differences using overlap weighting.</p><p><strong>Results: </strong>24 340 paediatric RVI hospitalizations (RSV = 8640; influenza = 9400; COVID-19 = 6300) and 82 635 adult RVI hospitalizations (RSV = 1553; influenza = 10 454; COVID-19 = 70 628) were included. In children, post-RSV hospitalization, higher risk and excess burden (EB) per 1000 individuals of any overall new-incident diagnosis were observed when contrasted against COVID-19/influenza (COVID-19: adjusted hazard ratio [aHR] = 1.63 [95% CI: 1.24-2.14], EB = 9.83 [95% CI: 5.26-14.41]; influenza: aHR = 1.76 [95% CI: 1.37-2.28], EB = 10.91 [95% CI: 6.78-15.04]); risks of respiratory sequelae predominated. In adults, though there was no significant difference in overall risk of post-acute sequelae between RSV and COVID-19/influenza, elevated risk of cardiovascular symptoms (aHR = 1.58 [95% CI: 1.13-2.22]) and other neurological disorders (aHR = 1.92 [95% CI: 1.31-2.80]) was observed in RSV hospitalizations vs. COVID-19.</p><p><strong>Discussion: </strong>Although risks of predominantly respiratory sequelae were elevated post-RSV hospitalization in children vs. COVID-19 or influenza, higher risk of extra-pulmonary sequelae (cardiovascular/neurological complications) was observed post-RSV hospitalization vs. COVID-19 in adults. Elevated risks at extremes of age highlight the importance of RSV vaccination in these vulnerable groups.</p>","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":" ","pages":""},"PeriodicalIF":10.9,"publicationDate":"2025-04-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143961148","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}