Joseph Meletiadis, Maria Siopi, Karin Meinike Jørgensen, Pilar Escribano, Henrich van de Lee, Jochem B Buil, Nathalie Friberg, Jesus Guinea, Maiken Cavling Arendrup
{"title":"Multicentre evaluation of a EUCAST-based agar-screening method for terbinafine and itraconazole susceptibility of Trichophyton spp.","authors":"Joseph Meletiadis, Maria Siopi, Karin Meinike Jørgensen, Pilar Escribano, Henrich van de Lee, Jochem B Buil, Nathalie Friberg, Jesus Guinea, Maiken Cavling Arendrup","doi":"10.1016/j.cmi.2025.07.012","DOIUrl":"10.1016/j.cmi.2025.07.012","url":null,"abstract":"<p><strong>Objectives: </strong>Resistance in Trichophyton species has become a global public health issue. Here, a four-well agar-screening method based on the European Committee on Antimicrobial Susceptibility Testing (EUCAST) definitive document (E.Def) 10.2 method was evaluated in five centres using a panel of terbinafine wild-type (WT) and non-WT Trichophyton isolates with the recently determined tentative epidemiological cut-offs of the E.Def 11.0 method.</p><p><strong>Methods: </strong>Forty-two Trichophyton isolates, all WT to itraconazole, 17 molecularly characterized terbinafine non-WT and 25 WT (non-WT/WT: 11/9 T. rubrum, 5/6 T. indotineae, 1/6 T. interdigitale and 0/4 T. mentagrophytes) were tested in five centres using four-well plates containing terbinafine 0.016 mg/L and 0.125 mg/L; itraconazole 1 mg/L and drug-free agar, respectively. Plates were inoculated (25 μL, 0.5 McFarland) and incubated for 5 to 7 days at 25 to 28°C. Visual growth comparable with drug-free control, ignoring faint growth/pinpoint colonies, indicated non-WT phenotype. Sensitivity and specificity in detecting Trichophyton non-WT isolates were calculated.</p><p><strong>Results: </strong>Most isolates produced sufficient growth after 5 days, whereas 6 to 10 of 42 isolates required 7 days of incubation. All isolates were correctly classified as WT to itraconazole by all five centres. The sensitivity (median [range among centres]) in detecting terbinafine non-WT isolates was 94% to 100% (95% CI: 79-100%), whereas the specificity for detecting WT isolates was 100%. Sensitivity and specificity were high across different species. Among the discrepancies, one false WT was observed with a T. rubrum strong mutant in one centre. WT T. indotineae grew on terbinafine 0.016 mg/L.</p><p><strong>Discussion: </strong>The multicentre evaluation confirmed that the agar-screening method was sensitive and specific for detecting terbinafine non-WT Trichophyton isolates and correctly identified itraconazole WT strains.</p>","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":" ","pages":""},"PeriodicalIF":8.5,"publicationDate":"2025-07-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144706585","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}
Dina Averbuch , Malgorzata Mikulska , Jan Styczynski , Anne Bergeron , Simone Cesaro , Raffaella Greco , Dionysios Neofytos , Francesco Onida , José Luis Piñana , Isabel Sanchez-Ortega , Paul E. Verweij , Ibrahim Yakoub-Agha , Rafael de la Camara , Per Ljungman
{"title":"Defining bloodstream and central venous catheter-related infections in patients following haematopoietic cell transplantation: position paper of the European Blood and Marrow Transplantation Society Infectious Diseases Working Party and Practice Harmonization and Guidelines Committee","authors":"Dina Averbuch , Malgorzata Mikulska , Jan Styczynski , Anne Bergeron , Simone Cesaro , Raffaella Greco , Dionysios Neofytos , Francesco Onida , José Luis Piñana , Isabel Sanchez-Ortega , Paul E. Verweij , Ibrahim Yakoub-Agha , Rafael de la Camara , Per Ljungman","doi":"10.1016/j.cmi.2025.06.037","DOIUrl":"10.1016/j.cmi.2025.06.037","url":null,"abstract":"<div><h3>Scope</h3><div>This position paper is intended for clinicians and data managers involved in the diagnosis, management, and reporting of bloodstream infection (BSI) and central venous catheter (CVC)-related BSI and CVC-related local skin/soft-tissue infections (lSSTI) in haematopoietic cell transplant (HCT) recipients.</div></div><div><h3>Methods</h3><div>The panel reviewed the relevant guidelines on BSI and CVC-related lSSTI definitions, and their applicability to HCT recipients. We developed practical recommendations aiming to establish their standardized reporting considering the unique features of HCT recipients.</div></div><div><h3>Questions addressed by the position paper</h3><div>.</div></div><div><h3>Primary BSI definitions</h3><div>Adequate blood volume is crucial for correct sampling. Definite BSI is defined as non-commensal pathogen identified by one positive culture or non-culture-based test, or two separate positive blood cultures with commensal pathogen, accompanied by any clinical or inflammatory markers deterioration. One positive blood culture set with viridans group <em>Streptococci</em> accompanied by clinical or inflammatory markers deterioration is defined as a probable BSI. After the validity confirmation, each primary BSI should be assessed for being a catheter-related BSI and/or mucosal barrier injury BSI; this terminology is not exclusive. CVC is considered a definite BSI source when the same pathogen grows from the cultures obtained from the CVC tip/hub and peripheral blood; confirmed by the differential time to positivity test or quantitative criteria. Mucosal barrier injury is considered a source when an intestinal pathogen grows in a patient with an appropriate clinical context.</div></div><div><h3>CVC-related lSSTI definitions</h3><div>CVC-related lSSTI (e.g. exit site, tunnel infection) should be defined as clinically or microbiologically documented (or both).</div></div><div><h3>Definition of recurrence and attributable mortality</h3><div>Relapse should be differentiated from reinfection when reporting recurrence. We propose reporting 30-day mortality after BSI. Attributable mortality is defined if death directly attributed to BSI by the treating physician assessment. Uniform definition and reporting of BSI types will improve the analysis of their rates, related outcomes, and efficacy of preventative and treatment measures.</div></div>","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":"31 10","pages":"Pages 1667-1676"},"PeriodicalIF":8.5,"publicationDate":"2025-07-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144697806","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}
Tuomas Aro, Tuuve A Häkkinen, Ville Holmberg, Mikael Kajova, Anu Kantele
{"title":"War on antimicrobial resistance: high carriage rates of multidrug-resistant bacteria among war-injured Ukrainian refugees.","authors":"Tuomas Aro, Tuuve A Häkkinen, Ville Holmberg, Mikael Kajova, Anu Kantele","doi":"10.1016/j.cmi.2025.07.010","DOIUrl":"10.1016/j.cmi.2025.07.010","url":null,"abstract":"","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":" ","pages":""},"PeriodicalIF":8.5,"publicationDate":"2025-07-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144697808","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}
Mathias Weis Damkjær , David Ruben Teindl Laursen , Mia Elkjær , Oke Gerke , Andreas Lundh , Asbjørn Hróbjartsson , Jeppe B. Schroll
{"title":"Preapproval and postapproval diagnostic test accuracy of food and drug administration–authorized rapid antigen SARS-CoV-2 tests used according to instruction: a systematic review and meta-analysis","authors":"Mathias Weis Damkjær , David Ruben Teindl Laursen , Mia Elkjær , Oke Gerke , Andreas Lundh , Asbjørn Hróbjartsson , Jeppe B. Schroll","doi":"10.1016/j.cmi.2025.07.009","DOIUrl":"10.1016/j.cmi.2025.07.009","url":null,"abstract":"<div><h3>Background</h3><div>Manufacturers claim high sensitivity for rapid antigen SARS-CoV-2 tests on product labels, yet systematic reviews report considerably lower sensitivity.</div></div><div><h3>Objectives</h3><div>This study aimed to describe study characteristics and compare the sensitivity and specificity of United States Food and Drug Administration (FDA)-approved rapid antigen SARS-CoV-2 tests in preapproval vs. postapproval studies.</div></div><div><h3>Methods</h3><div>Methods include systematic review and meta-analysis.</div></div><div><h3>Data sources</h3><div>Data sources include FDA website, Medline, Embase, and Google Scholar.</div></div><div><h3>Study eligibility criteria</h3><div>Study eligibility criteria include diagnostic test accuracy studies according to the instruction for use.</div></div><div><h3>Participants</h3><div>Participants include patients with symptoms of COVID-19.</div></div><div><h3>Tests</h3><div>Test includes rapid antigen SARS-CoV-2 tests.</div></div><div><h3>Reference standard</h3><div>Reference standard includes RT-PCR.</div></div><div><h3>Assessment of risk of bias</h3><div>Assessment of risk of bias was conducted using the Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2) tool.</div></div><div><h3>Methods of data synthesis</h3><div>Methods of data synthesis include bivariate binomial-normal restricted maximum likelihood random-effect meta-analysis and meta-regressions applying the delta method and likelihood-ratio tests.</div></div><div><h3>Results</h3><div>We identified postapproval studies for 13 of 61 (21%) rapid antigen tests, of which nine tests had eligible studies. The analysis incorporated 13 preapproval studies (591 patients with COVID-19, 3155 participants) and 26 postapproval studies (2765 patients with COVID-19, 12 444 participants). The pooled sensitivity for preapproval and postapproval studies was 86.5% (95% CI: 83.3–89.1%) and 84.5% (95% CI: 81.2–87.3%), respectively. The absolute difference was 2.0% (95% CI: −1.9% to 6.2%) and (0%, 95% CI: −0.6% to 0.6%) for sensitivity and specificity, respectively. Two of the nine tests had lower sensitivity in postapproval studies.</div></div><div><h3>Discussion</h3><div>Our study found that sensitivity estimates from postapproval studies on FDA-approved rapid antigen tests are largely consistent with manufacturers' estimates. However, for two of the nine tests, postapproval sensitivity was lower than the manufacturers' high estimates. Differences in sensitivity observed in prior systematic reviews likely result from variations in study populations, not bias in study conduct. Given that 79% of FDA-approved rapid antigen tests lacked postapproval studies, ongoing evaluations are needed to ensure alignment with clinical expectations.</div></div>","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":"31 10","pages":"Pages 1630-1638"},"PeriodicalIF":8.5,"publicationDate":"2025-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144667250","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":"Clinical performance of a genotyping assay based on a hybrid capture technique in cervical cancer screening in China: a prospective population-based multicentre cohort study.","authors":"Jian Yin, Sumeng Wang, Shaokai Zhang, Wen Chen, Qinjing Pan, Xun Zhang, Xiaodong Cheng, Xibin Sun, Fanghui Zhao, Youlin Qiao","doi":"10.1016/j.cmi.2025.07.004","DOIUrl":"10.1016/j.cmi.2025.07.004","url":null,"abstract":"<p><strong>Objectives: </strong>We aimed to assess the clinical performance of DH3, a hybrid capture assay that separately detects human papillomavirus (HPV) 16/18 and 12 other HPV types, for primary screening for cervical cancer in the general population, following Chinese guidelines.</p><p><strong>Methods: </strong>A total of 9379 eligible women aged 21 to 64 years from three centres underwent baseline screening with DH3 and liquid-based cytology (LBC), and were subsequently followed for 3 years. The diagnostic performance of HPV testing (DH3) and LBC-including sensitivity, specificity, positive predictive value (absolute risk), and negative predictive value-was evaluated for the detection of cervical intraepithelial neoplasia grade 2 or worse (CIN2+) Lesions.</p><p><strong>Results: </strong>At baseline, 146 (1.56%) participants were identified with CIN2+ lesions. Compared with LBC with reflex high-risk HPV (HR-HPV), primary HR-HPV with reflex LBC showed a significantly higher sensitivity (95.89% [95% CI: 91.33%-98.10%] vs. 84.93% [95% CI: 78.24%-89.83%], P<sub>McNemar[McN]</sub> = 0.004), and a marginally lower specificity (89.65% [95% CI: 89.01%-90.25%] vs. 91.61% [95% CI: 91.02%-92.15%], P<sub>McN</sub> <0.001) for detecting CIN2+. 7747 (82.6% follow-up rate) women completed the 3-year follow-up, during which 236 (3.00%) were cumulatively diagnosed with CIN2+. HR-HPV with reflex LBC demonstrated significantly higher sensitivity than LBC with reflex HR-HPV (91.95% [95% CI: 87.77%-94.79%] vs. 63.56% [95% CI: 57.25%-59.44%], P<sub>McN</sub> <0.001), whereas both methods exhibited similar specificity (90.57% [95% CI: 89.89%-91.21%] vs. 91.37% [95% CI: 90.72%-91.99%], P<sub>McNr</sub> = 0.062) for CIN2+. The colposcopy referral rates for the two algorithms were also comparable (5.77% (447/7747) vs. 5.38% (417/7747), p 0.294). In addition, individuals positive for HPV16/18 had a 3-year absolute risk of CIN2+ exceeding 48%. In comparison, the risk was only 0.28% (19/6822) in the HPV-negative population, markedly >1.24% (86/6949) risk observed in individuals with normal cytology. Limiting the analysis to women aged ≥30 yielded similar results.</p><p><strong>Discussion: </strong>Our study indicates that DH3 exhibits dependable clinical performance in cervical screening. The validated HPV test is expected to enhance the quality of population-based screening.</p>","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":" ","pages":""},"PeriodicalIF":8.5,"publicationDate":"2025-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144648762","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}
Silje Rebekka Heltveit-Olsen, Egill Snaebjörnsson Arnljots, Pär-Daniel Sundvall, Ronny Gunnarsson, Anna Kowalczyk, Maciej Godycki-Cwirko, Tamara N Platteel, Wim G Groen, Sara Sofia Lithén, Sofia Sundvall, Christina Åhrén, Nils Grude, Theo J M Verheij, Cees M P M Hertogh, Morten Lindbæk, Sigurd Høye
{"title":"Methenamine hippurate as prophylaxis for recurrent urinary tract infections in older women-a triple-blind, randomised, placebo-controlled, phase IV trial (ImpresU).","authors":"Silje Rebekka Heltveit-Olsen, Egill Snaebjörnsson Arnljots, Pär-Daniel Sundvall, Ronny Gunnarsson, Anna Kowalczyk, Maciej Godycki-Cwirko, Tamara N Platteel, Wim G Groen, Sara Sofia Lithén, Sofia Sundvall, Christina Åhrén, Nils Grude, Theo J M Verheij, Cees M P M Hertogh, Morten Lindbæk, Sigurd Høye","doi":"10.1016/j.cmi.2025.07.006","DOIUrl":"10.1016/j.cmi.2025.07.006","url":null,"abstract":"<p><strong>Objectives: </strong>This study aims to investigate the preventive effect of the antiseptic methenamine hippurate on recurrent urinary tract infections (rUTIs) in older women.</p><p><strong>Methods: </strong>Triple-blind, randomised, placebo-controlled phase IV trial with a 6-month treatment period and a 6-month follow-up. Women ≥70 years with rUTIs were recruited from general practice in Norway, Sweden, Poland, and The Netherlands. Recruitment started in December 2019, with follow-up completed at the end of June 2023. Participants were randomly assigned to methenamine hippurate 1g × 2 or placebo 1 tablet × 2 for 6 months. The primary outcome was the number of antibiotic treatments for urinary tract infections (UTIs) during the treatment period. Secondary outcomes included the number of antibiotic treatments for UTIs during the follow-up period, UTI symptom severity and episode duration. Differences in complications were measured as safety outcomes.</p><p><strong>Results: </strong>Of 289 recruited women, 281 (97%) were included in the main analysis (140 in the methenamine hippurate group, 141 in the placebo group). During the treatment period, the methenamine hippurate group had a lower incidence of antibiotic treatments for UTIs than the placebo group, with an incidence rate ratio of 0.75 (95% CI: 0.57-1.0, p 0.049). In the follow-up period, the ratio was reversed: the methenamine hippurate group had a higher incidence of antibiotic treatments for UTIs than the placebo group, with an incidence rate ratio of 1.7 (95% CI:1.3-2.3, p<0.001). There were no important differences in UTI symptom severity/duration or complications between the groups.</p><p><strong>Discussion: </strong>Methenamine hippurate reduces the frequency of rUTIs in older women with a point estimate of a 25% reduction, suggesting advantages over low-dose antibiotic prophylaxis because of its low potential for selection for antimicrobial resistance and mild side effects. However, discontinuation after 6-month treatment duration seems to increase the risk of UTI relapses, and physicians should be aware of this risk when initiating or discontinuing treatment.</p><p><strong>Trial registration number: </strong>ClinicalTrials.gov Registry (NCT04077580); EudraCT: 2018-002235.</p>","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":" ","pages":""},"PeriodicalIF":8.5,"publicationDate":"2025-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144648764","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}
Jari Verbunt, Freek G Bouwman, Suzan van Mens, Rogier van der Zanden, Frank Stassen, Paul Savelkoul
{"title":"Lyophilized vancomycin-hydrochloride for intravenous use retains full bactericidal activity and molecular stability 20 years postexpiration.","authors":"Jari Verbunt, Freek G Bouwman, Suzan van Mens, Rogier van der Zanden, Frank Stassen, Paul Savelkoul","doi":"10.1016/j.cmi.2025.07.007","DOIUrl":"10.1016/j.cmi.2025.07.007","url":null,"abstract":"","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":" ","pages":""},"PeriodicalIF":8.5,"publicationDate":"2025-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144648763","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}
Clément Vulin , Julian Sutter , Tiziano A. Schweizer , Federica Andreoni , Julian Baer , Willy Isao Steiger , Alexandra Bernasconi , Karl Bulut , Roger D. Kouyos , Brunella Posteraro , Maurizio Sanguinetti , Annelies S. Zinkernagel
{"title":"Screening clinical Candida albicans isolates for invasiveness by mimicking the human environment","authors":"Clément Vulin , Julian Sutter , Tiziano A. Schweizer , Federica Andreoni , Julian Baer , Willy Isao Steiger , Alexandra Bernasconi , Karl Bulut , Roger D. Kouyos , Brunella Posteraro , Maurizio Sanguinetti , Annelies S. Zinkernagel","doi":"10.1016/j.cmi.2025.07.003","DOIUrl":"10.1016/j.cmi.2025.07.003","url":null,"abstract":"<div><h3>Objectives</h3><div><em>Candida albicans</em> virulence is associated with filamentation, triggered by environmental factors encountered in the host. Here, we monitored the growth behaviour of <em>C. albicans</em> isolated from a patient's abscess. We also established an <em>in vitro</em> screening framework of filamentation to assess the invasiveness potential of 10 clinical isolates.</div></div><div><h3>Methods</h3><div>Routine microbiology testing and convenience sampling were used for patients' selection. We monitored the colony appearance time of one abscess isolate <em>ex vivo</em> using time-lapse imaging. Filamentation patterns of 10 isolates were followed >14 days using 48 variations of growth conditions (glucose and nitrogen concentrations, pH, and temperature) to mimic host environment fluctuations. An automated image analysis pipeline was developed to quantify filamentation. Filamentation was also tested by growing isolates on modified filtration membranes, mimicking physical human body barriers.</div></div><div><h3>Results</h3><div>The abscess isolate displayed heterogeneous colony appearance times and filamentation morphologies, indicating phenotypic heterogeneity within a growing population. Filamentation of all isolates was growth parameter- and isolate-dependent. Based on their filamentation response to environmental changes, the isolates clustered into three distinct groups, reflecting their site of isolation in the host. Colony transmigration on modified filtration membranes was a predictor for filamentation on agar.</div></div><div><h3>Discussion</h3><div>We observed diverse filamentation morphologies in all isolates, indicating a phenotypically heterogeneous behaviour. Using our newly established screening framework, we could group isolates based on their isolation site, showing a link between filamentation morphology and invasive potential of <em>C. albicans</em> isolates.</div></div>","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":"31 10","pages":"Pages 1726-1732"},"PeriodicalIF":8.5,"publicationDate":"2025-07-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144636445","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}