Pub Date : 2024-07-14DOI: 10.1016/j.cmi.2024.07.002
Jesús Guinea, Eva Alcoceba, Eduardo Padilla, Aída Ramírez, Elena De Carolis, Maurizio Sanguinetti, María Muñoz-Algarra, Teresa Durán-Valle, Inmaculada Quiles-Melero, Paloma Merino, Fernando González-Romo, Aída Sánchez-García, Elia Gómez-García-de-la-Pedrosa, Ana Pérez-Ayala, María Ángeles Mantecón-Vallejo, Javier Pemán, María Soledad Cuétara, Nelly Daniela Zurita, Coral García-Esteban, María Del Carmen Martínez-Jiménez, Miguel Ángel Sánchez Castellano, Elena Reigadas, Patricia Muñoz, Pilar Escribano
Objectives: We propose fast and accurate molecular detection of the Y132F ERG11p substitution directly on pure-cultured Candida parapsilosis isolates. We also assessed a discriminative genotyping scheme to track circulating genotypes.
Methods: A total of 223 C. parapsilosis isolates (one patient each) from 20 hospitals, located in Spain and Italy were selected. Isolates were fluconazole-resistant (n = 94; harbouring the Y132F ERG11p substitution [n = 85], the G458S substitution [n = 6], the R398I substitution [n = 2], or the wild-type ERG11 gene sequence) or fluconazole-susceptible (n = 129). Two targeted-A395T-mutation PCR formats (conventional and real-time) were engineered and optimized on fluconazole-susceptible and fluconazole-resistant pure-cultured isolates, thus skipping DNA extraction. Two genotyping schemes were compared: Scheme 1 (CP1, CP4a, CP6, and B markers), and Scheme 2 (6A, 6B, 6C, CP1, CP4a, and CP6 markers).
Results: The screening performed using both PCR formats showed 100% specificity (fluconazole-susceptible isolates; n = 129/129) and sensitivity (Y132F isolates; n = 85/85) values; however, results were available in 3 and 1.5 hours with the conventional and real-time PCR formats, respectively. Overall, Scheme 1 showed higher genetic diversity than Scheme 2, as shown by the number of alleles detected (n = 98; mean 23, range 13-38), the significantly higher observed and expected heterozygosity, and the probability of identity index (2.5 × 10-6). Scheme 2 markers did not provide further genotypic discrimination of Y132F fluconazole-resistant genotypes.
Conclusion: Both proposed PCR formats allow us to speed up the accurate detection of substitution Y132F ERG11p in C. parapsilosis isolates with 100% specificity and sensitivity. In addition, we recommend CP1, CP4a, CP6, and B microsatellite markers for genotyping fluconazole-resistant isolates.
{"title":"Fluconazole-resistant Candida parapsilosis: fast detection of the Y132F ERG11p substitution, and a proposed microsatellite genotyping scheme.","authors":"Jesús Guinea, Eva Alcoceba, Eduardo Padilla, Aída Ramírez, Elena De Carolis, Maurizio Sanguinetti, María Muñoz-Algarra, Teresa Durán-Valle, Inmaculada Quiles-Melero, Paloma Merino, Fernando González-Romo, Aída Sánchez-García, Elia Gómez-García-de-la-Pedrosa, Ana Pérez-Ayala, María Ángeles Mantecón-Vallejo, Javier Pemán, María Soledad Cuétara, Nelly Daniela Zurita, Coral García-Esteban, María Del Carmen Martínez-Jiménez, Miguel Ángel Sánchez Castellano, Elena Reigadas, Patricia Muñoz, Pilar Escribano","doi":"10.1016/j.cmi.2024.07.002","DOIUrl":"10.1016/j.cmi.2024.07.002","url":null,"abstract":"<p><strong>Objectives: </strong>We propose fast and accurate molecular detection of the Y132F ERG11p substitution directly on pure-cultured Candida parapsilosis isolates. We also assessed a discriminative genotyping scheme to track circulating genotypes.</p><p><strong>Methods: </strong>A total of 223 C. parapsilosis isolates (one patient each) from 20 hospitals, located in Spain and Italy were selected. Isolates were fluconazole-resistant (n = 94; harbouring the Y132F ERG11p substitution [n = 85], the G458S substitution [n = 6], the R398I substitution [n = 2], or the wild-type ERG11 gene sequence) or fluconazole-susceptible (n = 129). Two targeted-A395T-mutation PCR formats (conventional and real-time) were engineered and optimized on fluconazole-susceptible and fluconazole-resistant pure-cultured isolates, thus skipping DNA extraction. Two genotyping schemes were compared: Scheme 1 (CP1, CP4a, CP6, and B markers), and Scheme 2 (6A, 6B, 6C, CP1, CP4a, and CP6 markers).</p><p><strong>Results: </strong>The screening performed using both PCR formats showed 100% specificity (fluconazole-susceptible isolates; n = 129/129) and sensitivity (Y132F isolates; n = 85/85) values; however, results were available in 3 and 1.5 hours with the conventional and real-time PCR formats, respectively. Overall, Scheme 1 showed higher genetic diversity than Scheme 2, as shown by the number of alleles detected (n = 98; mean 23, range 13-38), the significantly higher observed and expected heterozygosity, and the probability of identity index (2.5 × 10<sup>-6</sup>). Scheme 2 markers did not provide further genotypic discrimination of Y132F fluconazole-resistant genotypes.</p><p><strong>Conclusion: </strong>Both proposed PCR formats allow us to speed up the accurate detection of substitution Y132F ERG11p in C. parapsilosis isolates with 100% specificity and sensitivity. In addition, we recommend CP1, CP4a, CP6, and B microsatellite markers for genotyping fluconazole-resistant isolates.</p>","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":null,"pages":null},"PeriodicalIF":10.9,"publicationDate":"2024-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141603334","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}
Pub Date : 2024-07-11DOI: 10.1016/j.cmi.2024.07.009
Benjamin Davido, Bruno Mégarbane, Paul Loubet
{"title":"COVID-19 surge during summer 2024: the phantom menace?","authors":"Benjamin Davido, Bruno Mégarbane, Paul Loubet","doi":"10.1016/j.cmi.2024.07.009","DOIUrl":"10.1016/j.cmi.2024.07.009","url":null,"abstract":"","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":null,"pages":null},"PeriodicalIF":10.9,"publicationDate":"2024-07-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141603333","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}
Pub Date : 2024-07-11DOI: 10.1016/j.cmi.2024.07.010
Antoine Aupaix, Samy Mzougui, Reza Soleimani
{"title":"Impact of susceptible, increased exposure, a new definition of the former intermediate susceptibility category, introduced by the European Committee for Antimicrobial Susceptibility Testing on antimicrobial susceptibility testing evaluation.","authors":"Antoine Aupaix, Samy Mzougui, Reza Soleimani","doi":"10.1016/j.cmi.2024.07.010","DOIUrl":"10.1016/j.cmi.2024.07.010","url":null,"abstract":"","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":null,"pages":null},"PeriodicalIF":10.9,"publicationDate":"2024-07-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141603335","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}
Pub Date : 2024-07-11DOI: 10.1016/j.cmi.2024.07.007
{"title":"Quantifying the impact of COVID-19-related restrictions on antibiotic resistance","authors":"","doi":"10.1016/j.cmi.2024.07.007","DOIUrl":"10.1016/j.cmi.2024.07.007","url":null,"abstract":"","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":null,"pages":null},"PeriodicalIF":10.9,"publicationDate":"2024-07-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141603337","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}
Objectives: The weekly rifapentine plus isoniazid for 3 months (3HP) improves completion rate of latent tuberculosis infection treatment, but flu-like symptoms are common. The novel 1HP regimen, involving daily rifapentine plus isoniazid for 28 days, has demonstrated low toxicity in HIV-infected populations. We aimed to investigate whether 1HP has a lower incidence rate of systemic drug reaction (SDR) compared with 3HP during treatment in non-HIV populations.
Methods: This randomized, multicentre trial compared the completion rate and risks of SDRs of 1HP and 3HP in aged ≥13 years non-HIV subjects with latent tuberculosis infection between September 2019 and September 2023 (ClinicalTrials.gov: NCT04094012). We also investigated associations between SDRs and plasma levels of drugs and their metabolites.
Results: A total of 251 and 239 individuals were randomly assigned to 1HP and 3HP groups, respectively, with completion rates of 82.9% (208/251) and 84.5% (202/239), respectively. Among them, 12.7% (32/251) and 10.9% (26/239) of 1HP and 3HP groups experienced SDRs, respectively (p 0.522), predominantly urticaria in 1HP group (59.4% [19/32]) and flu-like syndrome in 3HP group (80.8% [21/26]). Among participants experiencing SDRs, 43.8% (14/32) and 34.6% (9/26) in 1HP and 3HP groups, respectively, completed treatment (p 0.470). Cutaneous reactions were more common in 1HP than 3HP group (32.7% [82/251] vs. 13.0% [31/239], p < 0.001). In 1HP group, urticaria was associated with a higher plasma desacetyl-rifapentine level (ug/mL) at both 2 (median [interquartile range]: 36.06 [17.46-50.79] vs. 22.94 [14.67-31.65], p 0.018) and 6 hours (26.13 [15.80-53.06] vs. 29.83 [18.13-34.01], p 0.047) after dosing.
Discussion: In non-HIV population, the incidence rate of SDR under 1HP is not lower than 3HP. Notably, urticaria, rather than flu-like syndrome, was the predominant SDR associated 1HP. The findings of this study underscore the feasibility of 1HP regimen in non-HIV populations with a high-completion rate exceeding 80%.
{"title":"One-month daily and three-month weekly rifapentine plus isoniazid are comparable in completion rate and safety for latent tuberculosis infection in non-HIV Population: a randomized controlled trial.","authors":"Hung-Ling Huang, Meng-Rui Lee, Chih-Hsin Lee, Meng-Hsuan Cheng, Po-Liang Lu, Chau-Chyun Sheu, Jann-Yuan Wang, Inn-Wen Chong, Jinn-Moon Yang","doi":"10.1016/j.cmi.2024.06.024","DOIUrl":"10.1016/j.cmi.2024.06.024","url":null,"abstract":"<p><strong>Objectives: </strong>The weekly rifapentine plus isoniazid for 3 months (3HP) improves completion rate of latent tuberculosis infection treatment, but flu-like symptoms are common. The novel 1HP regimen, involving daily rifapentine plus isoniazid for 28 days, has demonstrated low toxicity in HIV-infected populations. We aimed to investigate whether 1HP has a lower incidence rate of systemic drug reaction (SDR) compared with 3HP during treatment in non-HIV populations.</p><p><strong>Methods: </strong>This randomized, multicentre trial compared the completion rate and risks of SDRs of 1HP and 3HP in aged ≥13 years non-HIV subjects with latent tuberculosis infection between September 2019 and September 2023 (ClinicalTrials.gov: NCT04094012). We also investigated associations between SDRs and plasma levels of drugs and their metabolites.</p><p><strong>Results: </strong>A total of 251 and 239 individuals were randomly assigned to 1HP and 3HP groups, respectively, with completion rates of 82.9% (208/251) and 84.5% (202/239), respectively. Among them, 12.7% (32/251) and 10.9% (26/239) of 1HP and 3HP groups experienced SDRs, respectively (p 0.522), predominantly urticaria in 1HP group (59.4% [19/32]) and flu-like syndrome in 3HP group (80.8% [21/26]). Among participants experiencing SDRs, 43.8% (14/32) and 34.6% (9/26) in 1HP and 3HP groups, respectively, completed treatment (p 0.470). Cutaneous reactions were more common in 1HP than 3HP group (32.7% [82/251] vs. 13.0% [31/239], p < 0.001). In 1HP group, urticaria was associated with a higher plasma desacetyl-rifapentine level (ug/mL) at both 2 (median [interquartile range]: 36.06 [17.46-50.79] vs. 22.94 [14.67-31.65], p 0.018) and 6 hours (26.13 [15.80-53.06] vs. 29.83 [18.13-34.01], p 0.047) after dosing.</p><p><strong>Discussion: </strong>In non-HIV population, the incidence rate of SDR under 1HP is not lower than 3HP. Notably, urticaria, rather than flu-like syndrome, was the predominant SDR associated 1HP. The findings of this study underscore the feasibility of 1HP regimen in non-HIV populations with a high-completion rate exceeding 80%.</p>","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":null,"pages":null},"PeriodicalIF":10.9,"publicationDate":"2024-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141598792","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}
Pub Date : 2024-07-09DOI: 10.1016/j.cmi.2024.07.004
Malte M Tetens, Lars Haukali Omland, Nanna S Andersen, Jette Bangsborg, Jacob Bodilsen, Ram B Dessau, Svend Ellermann-Eriksen, Charlotte Sværke Jørgensen, Jens Kjølseth Møller, Alex Christian Yde Nielsen, Michael Pedersen, Kirstine K Søgaard, Niels Obel, Anne-Mette Lebech
Objectives: To identify diagnostic opportunities, we investigated healthcare-seeking behaviour among patients with Lyme neuroborreliosis (LNB) within 28 weeks before diagnosis.
Methods: We conducted a population-based, nationwide matched nested case-control study (Denmark, 2009-2021). As cases, we included all Danish residents with LNB (positive Borrelia burgdorferi intrathecal antibody index test and cerebrospinal fluid pleocytosis). We randomly selected controls from the general population and matched 10:1 on date of birth and sex. Exposures were assignment of diagnostic codes for symptoms, contact to medical specialties, medical wandering, and undergoing diagnostic procedures. We calculated the weekly and 3-month proportions of individuals with exposures and calculated absolute risk differences with corresponding 95% CI.
Results: We included 1056 cases with LNB and 10 560 controls. Within 3 months before diagnosis, the most frequent assigned symptoms were pain (difference: 13.0%, 95% CI: 10.9-15.1). Cases with LNB exhibited increased contact with most specialties, particularly general practitioners (difference: 48.7%, 95% CI: 46.0-51.4), neurology (difference: 14.3%, 95% CI: 11.7-16.8), and internal medicine (difference: 11.1%, 95% CI: 8.7-13.5), and medical wandering (difference: 17.1%, 95% CI: 14.3-20.0). Common diagnostic procedures included imaging of the brain (difference: 10.2, 95% CI: 8.3-12.1), the spine (difference: 8.8%, 85% CI: 7.0-10.6), and the abdomen (difference: 7.2%, 95% CI: 5.4-9.1). The increase in healthcare-seeking behaviour was observed ≤12 weeks preceding diagnosis.
Discussion: Pain appears to be an ambiguous symptom of LNB, potentially contributing to delays in establishing the correct diagnosis. It would be difficult to identify patients with LNB more effectively as the increased healthcare-seeking behaviour preceding diagnosis is distributed across many medical specialties.
{"title":"Healthcare-seeking behaviour preceding diagnosis of Lyme neuroborreliosis: population-based nationwide matched nested case-control study.","authors":"Malte M Tetens, Lars Haukali Omland, Nanna S Andersen, Jette Bangsborg, Jacob Bodilsen, Ram B Dessau, Svend Ellermann-Eriksen, Charlotte Sværke Jørgensen, Jens Kjølseth Møller, Alex Christian Yde Nielsen, Michael Pedersen, Kirstine K Søgaard, Niels Obel, Anne-Mette Lebech","doi":"10.1016/j.cmi.2024.07.004","DOIUrl":"10.1016/j.cmi.2024.07.004","url":null,"abstract":"<p><strong>Objectives: </strong>To identify diagnostic opportunities, we investigated healthcare-seeking behaviour among patients with Lyme neuroborreliosis (LNB) within 28 weeks before diagnosis.</p><p><strong>Methods: </strong>We conducted a population-based, nationwide matched nested case-control study (Denmark, 2009-2021). As cases, we included all Danish residents with LNB (positive Borrelia burgdorferi intrathecal antibody index test and cerebrospinal fluid pleocytosis). We randomly selected controls from the general population and matched 10:1 on date of birth and sex. Exposures were assignment of diagnostic codes for symptoms, contact to medical specialties, medical wandering, and undergoing diagnostic procedures. We calculated the weekly and 3-month proportions of individuals with exposures and calculated absolute risk differences with corresponding 95% CI.</p><p><strong>Results: </strong>We included 1056 cases with LNB and 10 560 controls. Within 3 months before diagnosis, the most frequent assigned symptoms were pain (difference: 13.0%, 95% CI: 10.9-15.1). Cases with LNB exhibited increased contact with most specialties, particularly general practitioners (difference: 48.7%, 95% CI: 46.0-51.4), neurology (difference: 14.3%, 95% CI: 11.7-16.8), and internal medicine (difference: 11.1%, 95% CI: 8.7-13.5), and medical wandering (difference: 17.1%, 95% CI: 14.3-20.0). Common diagnostic procedures included imaging of the brain (difference: 10.2, 95% CI: 8.3-12.1), the spine (difference: 8.8%, 85% CI: 7.0-10.6), and the abdomen (difference: 7.2%, 95% CI: 5.4-9.1). The increase in healthcare-seeking behaviour was observed ≤12 weeks preceding diagnosis.</p><p><strong>Discussion: </strong>Pain appears to be an ambiguous symptom of LNB, potentially contributing to delays in establishing the correct diagnosis. It would be difficult to identify patients with LNB more effectively as the increased healthcare-seeking behaviour preceding diagnosis is distributed across many medical specialties.</p>","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":null,"pages":null},"PeriodicalIF":10.9,"publicationDate":"2024-07-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141589799","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}
Background: Prediction models help to target patients at risk of multidrug-resistant organism (MDRO) colonization or infection and could serve as tools informing clinical practices to prevent MDRO transmission and inappropriate empiric antibiotic therapy. However, there is limited evidence to identify which among the available models are of low risk of bias and suitable for clinical application.
Objectives: To identify, describe, appraise, and summarise the performance of all prognostic and diagnostic models developed or validated for predicting MDRO colonization or infection.
Data sources: Six electronic literature databases and clinical registration databases were searched until April 2022.
Study eligibility criteria: Development and validation studies of any multivariable prognostic and diagnostic models to predict MDRO colonization or infection in adults.
Participants: Adults (≥ 18 years old) without MDRO colonization or infection (in prognostic models) or with unknown or suspected MDRO colonization or infection (in diagnostic models).
Assessment of risk of bias: The Prediction Model Risk of Bias Assessment Tool was used to assess the risk of bias. Evidence certainty was assessed using the Grading of Recommendations Assessment, Development, and Evaluation approach.
Methods of data synthesis: Meta-analyses were conducted to summarize the discrimination and calibration of the models' external validations conducted in at least two non-overlapping datasets.
Results: We included 162 models (108 studies) developed for diagnosing (n = 135) and predicting (n = 27) MDRO colonization or infection. Models exhibited a high-risk of bias, especially in statistical analysis. High-frequency predictors were age, recent invasive procedures, antibiotic usage, and prior hospitalization. Less than 25% of the models underwent external validations, with only seven by independent teams. Meta-analyses for one diagnostic and two prognostic models only produced very low to low certainty of evidence.
Conclusions: The review comprehensively described the models for identifying patients at risk of MDRO colonization or infection. We cannot recommend which models are ready for application because of the high-risk of bias, limited validations, and low certainty of evidence from meta-analyses, indicating a clear need to improve the conducting and reporting of model development and external validation studies to facilitate clinical application.
{"title":"Prediction models for diagnosis and prognosis of the colonization or infection of multidrug-resistant organisms in adults: a systematic review, critical appraisal, and meta-analysis.","authors":"Xu Liu, Xi Liu, Chenyue Jin, Yuting Luo, Lianping Yang, Xinjiao Ning, Chao Zhuo, Fei Xiao","doi":"10.1016/j.cmi.2024.07.005","DOIUrl":"10.1016/j.cmi.2024.07.005","url":null,"abstract":"<p><strong>Background: </strong>Prediction models help to target patients at risk of multidrug-resistant organism (MDRO) colonization or infection and could serve as tools informing clinical practices to prevent MDRO transmission and inappropriate empiric antibiotic therapy. However, there is limited evidence to identify which among the available models are of low risk of bias and suitable for clinical application.</p><p><strong>Objectives: </strong>To identify, describe, appraise, and summarise the performance of all prognostic and diagnostic models developed or validated for predicting MDRO colonization or infection.</p><p><strong>Data sources: </strong>Six electronic literature databases and clinical registration databases were searched until April 2022.</p><p><strong>Study eligibility criteria: </strong>Development and validation studies of any multivariable prognostic and diagnostic models to predict MDRO colonization or infection in adults.</p><p><strong>Participants: </strong>Adults (≥ 18 years old) without MDRO colonization or infection (in prognostic models) or with unknown or suspected MDRO colonization or infection (in diagnostic models).</p><p><strong>Assessment of risk of bias: </strong>The Prediction Model Risk of Bias Assessment Tool was used to assess the risk of bias. Evidence certainty was assessed using the Grading of Recommendations Assessment, Development, and Evaluation approach.</p><p><strong>Methods of data synthesis: </strong>Meta-analyses were conducted to summarize the discrimination and calibration of the models' external validations conducted in at least two non-overlapping datasets.</p><p><strong>Results: </strong>We included 162 models (108 studies) developed for diagnosing (n = 135) and predicting (n = 27) MDRO colonization or infection. Models exhibited a high-risk of bias, especially in statistical analysis. High-frequency predictors were age, recent invasive procedures, antibiotic usage, and prior hospitalization. Less than 25% of the models underwent external validations, with only seven by independent teams. Meta-analyses for one diagnostic and two prognostic models only produced very low to low certainty of evidence.</p><p><strong>Conclusions: </strong>The review comprehensively described the models for identifying patients at risk of MDRO colonization or infection. We cannot recommend which models are ready for application because of the high-risk of bias, limited validations, and low certainty of evidence from meta-analyses, indicating a clear need to improve the conducting and reporting of model development and external validation studies to facilitate clinical application.</p>","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":null,"pages":null},"PeriodicalIF":10.9,"publicationDate":"2024-07-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141589800","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}
Pub Date : 2024-07-09DOI: 10.1016/j.cmi.2024.07.003
Leonard Leibovici, Julia Friedman
{"title":"Clinical Microbiology and Infection: how did we do in 2023?","authors":"Leonard Leibovici, Julia Friedman","doi":"10.1016/j.cmi.2024.07.003","DOIUrl":"10.1016/j.cmi.2024.07.003","url":null,"abstract":"","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":null,"pages":null},"PeriodicalIF":10.9,"publicationDate":"2024-07-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141589798","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}
Pub Date : 2024-07-06DOI: 10.1016/j.cmi.2024.06.028
Background
Before a new test can be routinely used in your laboratory, its reliability must be established in the laboratory where it will be used. International standards demand validation and verification procedures for new tests. The International Organization for Standardization (ISO) 15189 was recently updated, and the European Commission's In Vitro Diagnostic Regulation (IVDR) came into effect. These events will likely increase the need for validation and verification procedures.
Objectives
This paper aims to provide practical guidance in validating or verifying microbiology tests, including antimicrobial susceptibility tests in a clinical microbiology laboratory.
Sources
It summarizes and interprets certain parts of standards such as ISO 15189:2022, and regulations, such as IVDR 2017/746 regarding validation or verification of a new test in a routine clinical microbiology laboratory.
Content
The reasons for choosing a new test and the outline of the validation and verification plan are discussed. Furthermore, the following topics are touched upon: the choice of reference standard, number of samples, testing procedures, how to solve the discrepancies between results from new test and reference standard, and acceptance criteria. Arguments for selecting certain parameters (such as reference standard and sample size) and examples are given.
Implications
With the expected increase in validation and verification procedures because of the implementation of IVDR, this paper may aid in planning and executing these procedures.
{"title":"How to verify and validate a clinical microbiology test before it can be used in routine diagnostics: a practical guide","authors":"","doi":"10.1016/j.cmi.2024.06.028","DOIUrl":"10.1016/j.cmi.2024.06.028","url":null,"abstract":"<div><h3>Background</h3><p>Before a new test can be routinely used in your laboratory, its reliability must be established in the laboratory where it will be used. International standards demand validation and verification procedures for new tests. The International Organization for Standardization (ISO) 15189 was recently updated, and the European Commission's <em>In Vitro</em> Diagnostic Regulation (IVDR) came into effect. These events will likely increase the need for validation and verification procedures.</p></div><div><h3>Objectives</h3><p>This paper aims to provide practical guidance in validating or verifying microbiology tests, including antimicrobial susceptibility tests in a clinical microbiology laboratory.</p></div><div><h3>Sources</h3><p>It summarizes and interprets certain parts of standards such as ISO 15189:2022, and regulations, such as IVDR 2017/746 regarding validation or verification of a new test in a routine clinical microbiology laboratory.</p></div><div><h3>Content</h3><p>The reasons for choosing a new test and the outline of the validation and verification plan are discussed. Furthermore, the following topics are touched upon: the choice of reference standard, number of samples, testing procedures, how to solve the discrepancies between results from new test and reference standard, and acceptance criteria. Arguments for selecting certain parameters (such as reference standard and sample size) and examples are given.</p></div><div><h3>Implications</h3><p>With the expected increase in validation and verification procedures because of the implementation of IVDR, this paper may aid in planning and executing these procedures.</p></div>","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":null,"pages":null},"PeriodicalIF":10.9,"publicationDate":"2024-07-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1198743X24003094/pdfft?md5=64500cefc231bc624b5fa1df88bd3da7&pid=1-s2.0-S1198743X24003094-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141558271","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-06DOI: 10.1016/j.cmi.2024.06.031
Mark H Ebell, Dan J Merenstein, Bruce Barrett, Michelle Bentivegna, Cassie Hulme, Caroline Hamer, Sarah Walters, Alea Sabry, Shari Barlow
Objectives: To describe the symptoms, duration, severity, and microbiology of lower respiratory tract infection (LRTI) in outpatients.
Methods: Prospective cohort study of adults in US primary or urgent care with a chief complaint of cough and symptoms consistent with LRTI. Baseline data included demographics, signs, symptoms, and PCR for 46 viruses and bacteria. The severity of symptoms reported for ≤28 days follow-up via diary and text message. The Bronchitis severity score assessed severity at baseline; overall severity was defined as the area under the symptom severity curve.
Results: Of 718 patients with complete baseline data, 618 had valid PCR results, and 443 were followed until symptoms resolved. Of those with valid PCR, 100 (16.2%) had 1+ viruses detected, 211 (34.1%) had 1+ bacteria, and 168 (27.2%) had both. Symptoms more likely with viral or mixed infection included feverishness (36.7-38.4% vs. 18.5%), chills or sweats (36.0-38.1% vs. 17.9%), being generally unwell (78.2-81.3% vs. 64.9%), and myalgias (42.7-48.2% vs. 28.6%). Coloured sputum (42.9% vs. 23.2-29.5%) was more common with a bacterial infection. The mean duration of cough was 14.7 days with viruses (95% CI: 13.2-16.2), 17.3 with bacteria (95% CI: 15.9-18.6), 16.9 with mixed infection (95% CI: 15.2-18.6), and 18.4 with no detection (95% CI: 16.1-20.8). Overall severity of cough was lower for viral infections (20.9 points, 95% CI: 18.6-23.3) than for other groups (range 24.2-26.3). The most common potential bacterial pathogens were Haemophilus influenza (28.0%), Moraxella catarrhalis (16.2%), and Streptococcus pneumoniae (10.2%), whereas the most common viral pathogens were rhinovirus (17.3%), influenza (12.8%), SARS-CoV-2 (11.5%), and seasonal coronaviruses (8.1%).
Discussion: The mean duration of cough was 16.4 days. Consistent with European studies, the type of infection or potential pathogen was not an important predictor of the duration or severity of LRTI.
目的描述门诊患者下呼吸道感染(LRTI)的症状、持续时间、严重程度和微生物学:方法:前瞻性队列研究,对象为在美国初级或紧急医疗机构就诊、主诉为咳嗽且症状符合 LRTI 的成人。基线数据包括人口统计学、体征、症状以及 46 种病毒和细菌的 PCR 检测。通过日记和短信报告长达 28 天的随访症状严重程度。支气管炎严重程度评分(BSS)评估基线时的严重程度;总体严重程度定义为症状严重程度曲线下的面积:在基线数据完整的 718 名患者中,618 人的 PCR 结果有效,443 人接受了随访,直至症状缓解。在 PCR 结果有效的患者中,100 人(16.2%)检测到 1+ 病毒,211 人(34.1%)检测到 1+ 细菌,168 人(27.2%)同时检测到病毒和细菌。病毒感染或混合感染更可能出现的症状包括发热(36.7% 至 38.4% vs 18.5%)、发冷或出汗(36.0% 至 38.1% vs 17.9%)、全身不适(78.2% 至 81.3% vs 64.9%)和肌痛(42.7% 至 48.2% vs 28.6%)。细菌感染时,痰液带色(42.9% 对 23.2% 至 29.5%)的情况更为常见。病毒感染者咳嗽的平均持续时间为 14.7 天(95% CI 13.2-16.2),细菌感染者为 17.3 天(95% CI 15.9-18.6),混合感染者为 16.9 天(95% CI 15.2-18.6),未检测到病毒者为 18.4 天(95% CI 16.1-20.8)。病毒感染者的总体咳嗽严重程度(20.9 分,95% CI 18.6-23.3)低于其他组别(范围 24.2-26.3)。最常见的潜在细菌病原体是流感嗜血杆菌(28.0%)、白喉摩拉菌(16.2%)和肺炎链球菌(10.2%),而最常见的病毒病原体是鼻病毒(17.3%)、流感(12.8%)、SARS-CoV-2(11.5%)和季节性冠状病毒(8.1%):结论:咳嗽的平均持续时间为 16.4 天。结论:咳嗽的平均持续时间为 16.4 天。与欧洲的研究结果一致,感染类型或潜在病原体并不是预测 LRTI 持续时间或严重程度的重要因素。
{"title":"Acute cough in outpatients: what causes it, how long does it last, and how severe is it for different viruses and bacteria?","authors":"Mark H Ebell, Dan J Merenstein, Bruce Barrett, Michelle Bentivegna, Cassie Hulme, Caroline Hamer, Sarah Walters, Alea Sabry, Shari Barlow","doi":"10.1016/j.cmi.2024.06.031","DOIUrl":"10.1016/j.cmi.2024.06.031","url":null,"abstract":"<p><strong>Objectives: </strong>To describe the symptoms, duration, severity, and microbiology of lower respiratory tract infection (LRTI) in outpatients.</p><p><strong>Methods: </strong>Prospective cohort study of adults in US primary or urgent care with a chief complaint of cough and symptoms consistent with LRTI. Baseline data included demographics, signs, symptoms, and PCR for 46 viruses and bacteria. The severity of symptoms reported for ≤28 days follow-up via diary and text message. The Bronchitis severity score assessed severity at baseline; overall severity was defined as the area under the symptom severity curve.</p><p><strong>Results: </strong>Of 718 patients with complete baseline data, 618 had valid PCR results, and 443 were followed until symptoms resolved. Of those with valid PCR, 100 (16.2%) had 1+ viruses detected, 211 (34.1%) had 1+ bacteria, and 168 (27.2%) had both. Symptoms more likely with viral or mixed infection included feverishness (36.7-38.4% vs. 18.5%), chills or sweats (36.0-38.1% vs. 17.9%), being generally unwell (78.2-81.3% vs. 64.9%), and myalgias (42.7-48.2% vs. 28.6%). Coloured sputum (42.9% vs. 23.2-29.5%) was more common with a bacterial infection. The mean duration of cough was 14.7 days with viruses (95% CI: 13.2-16.2), 17.3 with bacteria (95% CI: 15.9-18.6), 16.9 with mixed infection (95% CI: 15.2-18.6), and 18.4 with no detection (95% CI: 16.1-20.8). Overall severity of cough was lower for viral infections (20.9 points, 95% CI: 18.6-23.3) than for other groups (range 24.2-26.3). The most common potential bacterial pathogens were Haemophilus influenza (28.0%), Moraxella catarrhalis (16.2%), and Streptococcus pneumoniae (10.2%), whereas the most common viral pathogens were rhinovirus (17.3%), influenza (12.8%), SARS-CoV-2 (11.5%), and seasonal coronaviruses (8.1%).</p><p><strong>Discussion: </strong>The mean duration of cough was 16.4 days. Consistent with European studies, the type of infection or potential pathogen was not an important predictor of the duration or severity of LRTI.</p>","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":null,"pages":null},"PeriodicalIF":10.9,"publicationDate":"2024-07-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141558270","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}