Clinical Microbiology and Infection最新文献

{"title":"Nirmatrelvir/ritonavir treatment and risk for post-acute sequelae of COVID-19 in older Singaporeans: author's response.","authors":"Liang En Wee, Jue Tao Lim, An Ting Tay, Calvin J Chiew, Barnaby Edward Young, Betty Wong, Ruth Lim, Ching Li Lee, Joyce Tan, Shawn Vasoo, David Chien Lye, Kelvin Bryan Tan","doi":"10.1016/j.cmi.2024.10.002","DOIUrl":"10.1016/j.cmi.2024.10.002","url":null,"abstract":"","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":" ","pages":""},"PeriodicalIF":10.9,"publicationDate":"2024-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142399607","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":"Preclinical and clinical studies in the drug development process of European Medicines Agency-approved non-HIV antiviral agents: a narrative review.","authors":"Lena Pracher, Markus Zeitlinger","doi":"10.1016/j.cmi.2024.10.001","DOIUrl":"10.1016/j.cmi.2024.10.001","url":null,"abstract":"<p><strong>Background: </strong>Viral diseases represent a substantial global health challenge, necessitating the urgent development of effective antiviral medications.</p><p><strong>Objectives: </strong>This review aims to present a thorough examination of systemic antiviral drugs approved by the European Medicines Agency (EMA) since its founding, excluding those targeting HIV, with a focus on preclinical and clinical studies in the drug development process.</p><p><strong>Sources: </strong>Data was extracted from the European Public Assessment Reports and Summary of Product Characteristics issued by the EMA.</p><p><strong>Content: </strong>In total, 21 currently approved agents were analysed with a focus on preclinical and clinical studies. The majority of substances have been approved for hepatitis C (38%) and B (19%) followed by influenza and SARS-CoV-2 (14% and 10%, respectively). A smaller subset obtained approval for the indications of hepatitis D, cytomegalovirus, and pox viruses. As for preclinical studies, heterogeneity in the methods used for efficacy studies was observed, which is at least partly explained by the diverse nature of viruses and their hosts and the lack of general guidelines for antiviral pharmacokinetics and pharmacodynamics studies by the EMA. Clinical studies varied in sample sizes, ranging from a few hundred to several thousand patients. Many antiviral agents have a high potential for cytochrome P450 (CYP) and other enzyme interactions, resulting in the need for a high number of drug-drug interaction studies. Special market authorizations are available, including conditional approval for urgently required drugs such as nirmatrelvir/ritonavir for the treatment of COVID-19, and authorization under exceptional circumstances when comprehensive data cannot be provided, as seen with tecovirimat for pox viruses.</p><p><strong>Implications: </strong>Streamlining the drug development process of antiviral substances and providing more guidelines would be crucial given the ongoing demand for effective treatment options for existing and new viral diseases.</p>","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":" ","pages":""},"PeriodicalIF":10.9,"publicationDate":"2024-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142399608","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":"Isoniazid resistance pattern among pulmonary tuberculosis patients in Bangladesh: An exploratory study.","authors":"Syed Mohammad Mazidur Rahman, Pushpita Samina, Tanjina Rahman, Ahammad Shafiq Sikder Adel, Rumana Nasrin, Mohammad Khaja Mafij Uddin, Md Jahid Hasan, Shahriar Ahmed, Paul Daru, Pronab Kumar Modak, Md Abdul Hamid Salim, Sardar Munim Ibna Mohsin, Sayera Banu","doi":"10.1016/j.cmi.2024.09.027","DOIUrl":"10.1016/j.cmi.2024.09.027","url":null,"abstract":"<p><strong>Objectives: </strong>In high tuberculosis (TB) burden countries such as Bangladesh, research and policy tend to focus on rifampicin (RIF)-resistant TB patients, leaving RIF-sensitive but isoniazid (INH)-resistant (Hr-TB) patients undiagnosed. Our study aims to determine the prevalence of INH resistance among pulmonary TB patients in selected health care facilities in Bangladesh.</p><p><strong>Methods: </strong>This study was conducted across nine TB Screening and Treatment Centres situated in Bangladesh. Sputum samples from 1084 Xpert-positive pulmonary TB patients were collected between April 2021 and December 2022 and cultured for drug susceptibility testing. Demographic and clinical characteristics of Hr-TB and drug-susceptible TB patients were compared.</p><p><strong>Results: </strong>Among available drug susceptibility testing results of 998 culture-positive isolates, the resistance rate of any INH regardless of RIF susceptibility was 6.4% (64/998, 95% CI: 4.9-8.2). The rate was significantly higher in previously treated (21.1%, 16/76, 95% CI: 12.0-34.2) compared with newly diagnosed TB patients (5.2%, 48/922, 95% CI: 3.8-6.9) (p < 0.001). The rate of Hr-TB was 4.5% (45/998, 95% CI: 3.3-6.0), which was also higher among previously treated patients (6.6%, 5/76, 95% CI: 1.4-13.5) compared with newly diagnosed TB patients (4.3%; 40/922, 95% CI: 3.1-5.9) (p 0.350). Most importantly, the rate of Hr-TB was more than double compared with MDR-TB (4.5%, 45/998, vs. 1.9%, 19/998) found in the current study.</p><p><strong>Discussion: </strong>This study reveals a high prevalence of Hr-TB, surpassing even that of the multi-drug-resistant TB in Bangladesh. This emphasizes the urgent need to adopt WHO-recommended molecular tools at the national level for rapid detection of INH resistance so that patients receive timely and appropriate treatment.</p>","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":" ","pages":""},"PeriodicalIF":10.9,"publicationDate":"2024-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142388594","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":"Complex mpox situation, 2024.","authors":"Pikka Jokelainen, Anne L Wyllie, Nitin Gupta, Aleksandra Barac, Effrossyni Gkrania-Klotsas, Casandra Bulescu, José Ramón Paño-Pardo, Marta Mora-Rillo, Martin P Grobusch, F-Xavier Lescure","doi":"10.1016/j.cmi.2024.09.028","DOIUrl":"10.1016/j.cmi.2024.09.028","url":null,"abstract":"","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":" ","pages":""},"PeriodicalIF":10.9,"publicationDate":"2024-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142388589","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":"Impact of C-reactive protein point-of-care testing on antibiotic prescriptions for children and adults with suspected respiratory tract infections in primary care: author's response.","authors":"Camille Jung, Xavier Wang, Corinne Levy, Robert Cohen, Robert Touitou","doi":"10.1016/j.cmi.2024.09.032","DOIUrl":"10.1016/j.cmi.2024.09.032","url":null,"abstract":"","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":" ","pages":""},"PeriodicalIF":10.9,"publicationDate":"2024-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142388591","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":"ESR and CRP: it is time to stop the zombie tests: author's response.","authors":"Brad Spellberg, Bassam Ghanem, Tom Boyles, Todd C Lee, Emily G McDonald","doi":"10.1016/j.cmi.2024.09.029","DOIUrl":"10.1016/j.cmi.2024.09.029","url":null,"abstract":"","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":" ","pages":""},"PeriodicalIF":10.9,"publicationDate":"2024-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142388590","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":"Introducing new antibiotics for multidrug-resistant bacteria: obstacles and the way forward.","authors":"Thomas Tängdén, Elena Carrara, Mona Mustafa Hellou, Dafna Yahav, Mical Paul","doi":"10.1016/j.cmi.2024.09.025","DOIUrl":"10.1016/j.cmi.2024.09.025","url":null,"abstract":"<p><strong>Background: </strong>Following intense efforts to revive the dry antibiotic research and development pipeline, a few highly awaited antibiotics with activity against multidrug-resistant (MDR) bacteria were recently approved.</p><p><strong>Objectives: </strong>We aim to highlight gaps in the evidence generated for new antibiotics by the time of their approval and to review the consequent limitations of treatment guidelines for priority MDR bacteria. We also report on the availability of the new antibiotics, reimbursement strategies allowing the use of these antibiotics in hospitals, and antibiotic stewardship efforts.</p><p><strong>Sources: </strong>We searched PubMed for phase 3 randomized controlled trials, guidelines, and publications on access, usage, regulatory aspects and antimicrobial stewardship of antibiotics approved for use against MDR bacteria between 2013 and 2023. Other sources included governmental and professional documents regarding policies for reimbursement and use of the new antibiotics.</p><p><strong>Content: </strong>Several gaps in the evidence available regarding the new antibiotics are described related to the trials' target populations, comparators, management algorithm within the trial, non-inferiority hypotheses, and assessment of resistance development within the studies. We highlight the risk of current guidelines to increase the usage of new antibiotics and consequently accelerate resistance development. Updated mapping of antibiotic availability reveals critical inequality in access to the new antibiotics. Finally, strategies used nationally in Europe to provide access to the new antibiotics are not sufficiently balanced by antibiotic stewardship efforts to calibrate the judicious use of the new antibiotics.</p><p><strong>Implications: </strong>Antibiotic resistance is an immediate threat. The present review highlights areas where more systematic and uniform strategies across countries and geographical regions are warranted to improve evidence, availability, and use of new broad-spectrum antibiotics.</p>","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":" ","pages":""},"PeriodicalIF":10.9,"publicationDate":"2024-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142388593","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":"Steroids for viral meningitis: a foe or a friend?","authors":"Rodrigo Hasbun","doi":"10.1016/j.cmi.2024.09.030","DOIUrl":"10.1016/j.cmi.2024.09.030","url":null,"abstract":"","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":" ","pages":""},"PeriodicalIF":10.9,"publicationDate":"2024-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142388596","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":"Pitfalls in generating robust malaria molecular evidence for SP-resistance.","authors":"Nimita Deora, Abhinav Sinha","doi":"10.1016/j.cmi.2024.09.026","DOIUrl":"10.1016/j.cmi.2024.09.026","url":null,"abstract":"","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":" ","pages":""},"PeriodicalIF":10.9,"publicationDate":"2024-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142388595","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":"In vitro activity of cefepime-enmetazobactam on carbapenem-resistant gram negatives.","authors":"Rémy A Bonnin, Katy Jeannot, Anne Santerre Henriksen, Juan Quevedo, Laurent Dortet","doi":"10.1016/j.cmi.2024.09.031","DOIUrl":"10.1016/j.cmi.2024.09.031","url":null,"abstract":"<p><strong>Objectives: </strong>Cefepime-enmetazobactam is a new β-lactam/βlactamase inhibitor combination with broad-spectrum activity against multidrug-resistant Enterobacterales, including extended-spectrum β-lactamase producers. This study evaluated the in vitro activity of cefepime-enmetazobactam towards a collection of carbapenem-resistant Enterobacterales (CRE), Pseudomonas aeruginosa and Acinetobacter baumannii compared to the other β-lactam/β-lactamase inhibitor combinations.</p><p><strong>Methods: </strong>The MIC of cefepime, cefepime-enmetazobactam, ceftazidime, ceftazidime-avibactam, meropenem, meropenem-vaborbactam, imipenem, imipenem-relebactam, and ertapenem were determined by broth microdilution on 2212 CRE, including 2089 carbapenemase producers (1000 OXA-48-like, 49 KPC, 697 NDM, 180 VIM, 1 IMP, 9 IMI, and 158 multiple carbapenemases) and 123 CRE that do not produce carbapenemase received at the French National Reference Centre (from March 1, 2023 to August 31, 2023), 50 P. aeruginosa, and 30 A. baumannii. All strains were fully sequenced.</p><p><strong>Results: </strong>We confirmed the absence of inhibitory activity of enmetazobactam towards metallo-β-lactamases. Cefepime-enmetazobactam and ceftazidime-avibactam exhibited a similar susceptibility (96.7% vs. 99.5%, respectively) on OXA-48-producers. Cefepime-enmetazobactam exhibited 66.9% and 63.3% susceptibility for CRE non-EPC and KPC, whereas those rates rose to 96.7%/95.9%, 93.4%/95.9%, and 95.9%/98.0% for ceftazidime-avibactam, imipenem-relebactam, and meropenem-vaborbactam, respectively. Low MICs (≤0.25 mg/L) were obtained for ceftazidime-avibactam-resistant KPC variants. Cefepime-enmetazobactam did not display a significant added value when compared with cefepime alone on Pseudomonas aeruginosa and Acinetobacter baumannii.</p><p><strong>Discussion: </strong>OXA-48 producers displayed high susceptibility to cefepime-enmetazobactam, which is similar to ceftazidime-avibactam, including for OXA-48 producers that coproduce a ceftazidime hydrolyzing enzyme (extended-spectrum β-lactamases or AmpC). In vivo experiments have to be implemented to confirm if cefepime-enmetazobactam might be a relevant alternative to ceftazidime-avibactam for the treatment of infections caused by OXA-48 producers.</p>","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":" ","pages":""},"PeriodicalIF":10.9,"publicationDate":"2024-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142388592","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}