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Real-world effectiveness of nirmatrelvir-ritonavir and molnupiravir in non-hospitalised adults with Covid-19: a population-based, retrospective cohort study cohort study. 尼马瑞韦-利托那韦和莫仑匹拉韦对非住院成人 Covid-19 患者的实际疗效:一项基于人群的回顾性队列研究。
IF 10.9 1区 医学
Clinical Microbiology and Infection Pub Date : 2024-11-04 DOI: 10.1016/j.cmi.2024.10.026
Anselm Jorda, Dominik Ensle, Hubert Eser, Florentin Glötzl, Benjamin Riedl, Marton Szell, Arschang Valipour, Alexander Zoufaly, Christoph Wenisch, Doris Haider, Heinz Burgmann, Florian Thalhammer, Florian Götzinger, Bernd Jilma, Robin Ristl, Ursula Karnthaler, Markus Zeitlinger
{"title":"Real-world effectiveness of nirmatrelvir-ritonavir and molnupiravir in non-hospitalised adults with Covid-19: a population-based, retrospective cohort study cohort study.","authors":"Anselm Jorda, Dominik Ensle, Hubert Eser, Florentin Glötzl, Benjamin Riedl, Marton Szell, Arschang Valipour, Alexander Zoufaly, Christoph Wenisch, Doris Haider, Heinz Burgmann, Florian Thalhammer, Florian Götzinger, Bernd Jilma, Robin Ristl, Ursula Karnthaler, Markus Zeitlinger","doi":"10.1016/j.cmi.2024.10.026","DOIUrl":"https://doi.org/10.1016/j.cmi.2024.10.026","url":null,"abstract":"<p><strong>Objectives: </strong>The real-world effectiveness of the oral antivirals nirmatrelvir-ritonavir and molnupiravir against the SARS-CoV-2 Omicron variant remains uncertain. We aimed to estimate their effectiveness in non-hospitalised adults with Covid-19.</p><p><strong>Methods: </strong>This retrospective cohort study used data from the Municipal Department for Public Health Services of Vienna, Austria, to identify non-hospitalised adults with confirmed SARS-CoV-2 infection between Jan-2022-May-2023. Nirmatrelvir-ritonavir users were compared with untreated controls and molnupiravir users with untreated controls by calculating adjusted risk differences (aRDs) using a covariate-adjusted logistic regression model with inverse probability weighting. Outcomes were hospitalisation and all-cause death within 28 days.</p><p><strong>Results: </strong>We identified 113,399 eligible cases (90,481 untreated controls, 12,166 nirmatrelvir-ritonavir users, and 10,752 molnupiravir users). Over 96% of the patients were immunised by previous infection or vaccination. In the nirmatrelvir-ritonavir analysis, the estimated risk of hospitalisation was 0.57% (95%CI, 0.35-0.78) in nirmatrelvir-ritonavir users and 1.09% (95%CI, 0.86-1.32) in untreated controls (aRD -0.53%; 95%CI, -0.77--0.28). The estimated risk of death was 0.0% (95%CI, 0.0-0.0) in nirmatrelvir-ritonavir users and 0.13% (95%CI, 0.08-0.18) in untreated controls (aRD -0.13%, 95%CI, -0.18--0.08). The number needed to treat to prevent hospitalisation and death was 190 (95%CI, 130-356) and 792 (95%CI, 571-1289), respectively. These statistically significant aRDs were restricted to the subgroup of patients ≥60 years. In the molnupiravir analysis, the estimated risk of hospitalisation was 1.36% (95%CI, 0.95-1.77) in molnupiravir users and 1.16% (95%CI, 0.93-1.39) in untreated controls (aRD 0.2%; 95%CI, -0.08-0.49). The estimated risk of death was 0.12% (95%CI, 0.01-0.23) in molnupiravir users and 0.14% (95%CI, 0.06-0.21) in untreated controls (aRD, -0.01%; 95%CI, -0.08--0.06).</p><p><strong>Conclusions: </strong>Among outpatients aged ≥60 years with Covid-19 in an Omicron-dominated era, treatment with nirmatrelvir-ritonavir was associated with a lower risk of hospitalisation and all-cause death within 28 days, albeit with wide confidence intervals and high numbers needed to treat. This finding was not observed in molnupiravir users and younger nirmatrelvir-ritonavir users.</p>","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":" ","pages":""},"PeriodicalIF":10.9,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142589885","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}
引用次数: 0
A phase 3 randomized trial of sulopenem vs. ertapenem in patients with complicated intraabdominal infections. 针对复杂腹腔内感染患者的舒洛培南与厄他培南 3 期随机试验。
IF 10.9 1区 医学
Clinical Microbiology and Infection Pub Date : 2024-11-02 DOI: 10.1016/j.cmi.2024.10.025
Michael W Dunne, Steven I Aronin, Anita F Das, Karthik Akinapelli, Jeanne Breen, Michael T Zelasky, Sailaja Puttagunta
{"title":"A phase 3 randomized trial of sulopenem vs. ertapenem in patients with complicated intraabdominal infections.","authors":"Michael W Dunne, Steven I Aronin, Anita F Das, Karthik Akinapelli, Jeanne Breen, Michael T Zelasky, Sailaja Puttagunta","doi":"10.1016/j.cmi.2024.10.025","DOIUrl":"https://doi.org/10.1016/j.cmi.2024.10.025","url":null,"abstract":"<p><strong>Objective: </strong>To demonstrate the noninferiority of intravenous (IV) sulopenem to IV ertapenem, each followed by an oral regimen, in adults with complicated intraabdominal infections (cIAI).</p><p><strong>Methods: </strong>Hospitalized adults with cIAI were randomized to 5 days of IV sulopenem followed by oral sulopenem etzadroxil/probenecid twice daily or 5 days of IV ertapenem followed by oral ciprofloxacin/metronidazole or amoxicillin-clavulanate depending on baseline pathogen susceptibility. The target treatment duration was 7-10 days. The primary (FDA-specified) endpoint was clinical response at Day 28 [Test-of-Cure (TOC)] in the micro-Modified Intent to Treat (micro-MITT) population.</p><p><strong>Results: </strong>674 patients were randomized. The two treatment arms were well-balanced. E. coli (395 patients) and B. fragilis (111 patients) were the most frequently isolated pathogens. Clinical success rates in the micro-MITT population were 81.9% (204/249) for sulopenem-treated patients and 87.9% (233/265) for ertapenem-treated patients. The lower bound of the confidence interval (CI) for the treatment difference of the primary endpoint was below the prespecified non-inferiority margin of -10.0 [treatment difference -6.0%, 95% CI [-12.2, 0.2]. In all other analysis populations, the lower limit of the 95% CI was above -10.0. Treatment emergent adverse events (all, 26.0% [87/335] vs 23.4% [78/333]; related, 6.0% [20/335] vs 5.1% [17/333]) were similar for sulopenem and ertapenem, respectively. Most events were mild to moderate in severity. There were more serious adverse events in the sulopenem arm (7.5% [25/335] vs 3.6% [12/333]), only two of which were considered possibly drug-related.</p><p><strong>Conclusions: </strong>Sulopenem IV followed by oral sulopenem etzadroxil/probenecid was not noninferior to ertapenem followed by oral step-down in treating cIAI in the micro-MITT population. This finding should be interpreted in the context of country regulations, as endpoint timing, primary analysis population and noninferiority margin may vary regionally. Both IV and oral sulopenem were well-tolerated; the oral formulation allowed patients with resistant pathogens to step down from IV therapy.</p><p><strong>Clinical trial registration: </strong>NCT03358576.</p>","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":" ","pages":""},"PeriodicalIF":10.9,"publicationDate":"2024-11-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142567534","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}
引用次数: 0
Re: 'Heightened incidence of adverse events associated with a live attenuated varicella vaccine strain that lacks critical genetic polymorphisms in ORF62' by Kang et al. 关于Kang等人撰写的 "水痘减毒活疫苗株缺乏ORF62的关键基因多态性导致不良反应发生率升高 "一文。
IF 10.9 1区 医学
Clinical Microbiology and Infection Pub Date : 2024-11-02 DOI: 10.1016/j.cmi.2024.10.024
Young Woo Han, Seung Hye Hong, Seung Gu Kang, Seong-Beom Park, Hye Young Kim
{"title":"Re: 'Heightened incidence of adverse events associated with a live attenuated varicella vaccine strain that lacks critical genetic polymorphisms in ORF62' by Kang et al.","authors":"Young Woo Han, Seung Hye Hong, Seung Gu Kang, Seong-Beom Park, Hye Young Kim","doi":"10.1016/j.cmi.2024.10.024","DOIUrl":"https://doi.org/10.1016/j.cmi.2024.10.024","url":null,"abstract":"","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":" ","pages":""},"PeriodicalIF":10.9,"publicationDate":"2024-11-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142567555","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}
引用次数: 0
'Measurement of circulating viral antigens post-SARS-CoV-2 infection in a multicohort study' - Author's reply. 在一项多队列研究中测量 SARS-CoV-2 感染后的循环病毒抗原"--作者回复。
IF 10.9 1区 医学
Clinical Microbiology and Infection Pub Date : 2024-11-01 DOI: 10.1016/j.cmi.2024.10.028
Zoe Swank, Elizabeth W Karlson, David R Walt
{"title":"'Measurement of circulating viral antigens post-SARS-CoV-2 infection in a multicohort study' - Author's reply.","authors":"Zoe Swank, Elizabeth W Karlson, David R Walt","doi":"10.1016/j.cmi.2024.10.028","DOIUrl":"https://doi.org/10.1016/j.cmi.2024.10.028","url":null,"abstract":"","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":" ","pages":""},"PeriodicalIF":10.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142567549","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}
引用次数: 0
Questioning the existence of Baggio-Yoshinari syndrome in Brazil. 质疑巴西是否存在巴乔-吉纳里综合征。
IF 10.9 1区 医学
Clinical Microbiology and Infection Pub Date : 2024-11-01 DOI: 10.1016/j.cmi.2024.10.027
Rodrigo Nunes Rodrigues-da-Silva, Laura Sant'anna Ataides, Rodrigo Nogueira Angerami, Marcos Vinícius da Silva, Elba Regina Sampaio de Lemos
{"title":"Questioning the existence of Baggio-Yoshinari syndrome in Brazil.","authors":"Rodrigo Nunes Rodrigues-da-Silva, Laura Sant'anna Ataides, Rodrigo Nogueira Angerami, Marcos Vinícius da Silva, Elba Regina Sampaio de Lemos","doi":"10.1016/j.cmi.2024.10.027","DOIUrl":"https://doi.org/10.1016/j.cmi.2024.10.027","url":null,"abstract":"","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":" ","pages":""},"PeriodicalIF":10.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142567552","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}
引用次数: 0
Epidemiology of human metapneumovirus among children with severe or very severe pneumonia in high pneumonia burden settings: the PERCH study experience. 肺炎高负担地区重症或极重症肺炎患儿的人类偏肺病毒流行病学:PERCH 研究经验。
IF 10.9 1区 医学
Clinical Microbiology and Infection Pub Date : 2024-11-01 DOI: 10.1016/j.cmi.2024.10.023
Ryo Miyakawa, Haijun Zhang, W Abdullah Brooks, Christine Prosperi, Henry C Baggett, Daniel R Feikin, Laura L Hammitt, Stephen R C Howie, Karen L Kotloff, Orin S Levine, Shabir A Madhi, David R Murdoch, Katherine L O'Brien, J Anthony G Scott, Donald M Thea, Martin Antonio, Juliet O Awori, Charatdao Bunthi, Amanda J Driscoll, Bernard Ebruke, Nicholas S Fancourt, Melissa M Higdon, Ruth A Karron, David P Moore, Susan C Morpeth, Justin M Mulindwa, Daniel E Park, Mohammed Ziaur Rahman, Mustafizur Rahman, Rasheed A Salaudeen, Pongpun Sawatwong, Phil Seidenberg, Samba O Sow, Milagritos D Tapia, Maria Deloria Knoll
{"title":"Epidemiology of human metapneumovirus among children with severe or very severe pneumonia in high pneumonia burden settings: the PERCH study experience.","authors":"Ryo Miyakawa, Haijun Zhang, W Abdullah Brooks, Christine Prosperi, Henry C Baggett, Daniel R Feikin, Laura L Hammitt, Stephen R C Howie, Karen L Kotloff, Orin S Levine, Shabir A Madhi, David R Murdoch, Katherine L O'Brien, J Anthony G Scott, Donald M Thea, Martin Antonio, Juliet O Awori, Charatdao Bunthi, Amanda J Driscoll, Bernard Ebruke, Nicholas S Fancourt, Melissa M Higdon, Ruth A Karron, David P Moore, Susan C Morpeth, Justin M Mulindwa, Daniel E Park, Mohammed Ziaur Rahman, Mustafizur Rahman, Rasheed A Salaudeen, Pongpun Sawatwong, Phil Seidenberg, Samba O Sow, Milagritos D Tapia, Maria Deloria Knoll","doi":"10.1016/j.cmi.2024.10.023","DOIUrl":"https://doi.org/10.1016/j.cmi.2024.10.023","url":null,"abstract":"<p><strong>Objectives: </strong>After respiratory syncytial virus (RSV), human metapneumovirus (hMPV) was the second-ranked pathogen attributed to severe pneumonia in the PERCH study. We sought to characterize hMPV-positive cases in high burden settings, which have limited data, by comparing to RSV-positive and other cases.</p><p><strong>Methods: </strong>Children aged 1-59 months hospitalized with suspected severe pneumonia and age/season-matched community controls in seven African and Asian countries had nasopharyngeal/oropharyngeal swabs tested by multiplex PCR for 32 respiratory pathogens, among other clinical and lab assessments at admission. Odds ratios adjusted for age and site (aOR) were calculated using logistic regression. Etiologic probability was estimated using Bayesian nested partial latent class analysis. Latent class analysis identified syndromic constellations of clinical characteristics.</p><p><strong>Results: </strong>HMPV was detected more frequently among cases (267/3887, 6.9%) than controls (115/4976, 2.3%), among cases with pneumonia chest X-ray findings (8.5%) than without (5.5%), and among controls with respiratory tract illness (3.8%) than without (1.8%; all p≤0.001). HMPV-positive cases were negatively associated with the detection of other viruses (aOR=0.18), especially RSV (aOR=0.11; all p<0.0001), and positively associated with the detection of bacteria (aORs 1.77, p=0.03). No single clinical syndrome distinguished hMPV-positive from other cases. Among hMPV-positive cases, 65.2% were aged <1 year and 27.5% had pneumonia danger signs; positive predictive value was 74.5%; mortality was 3.9%, similar to RSV-positive (2.4%) and lower than other cases (9.6%).</p><p><strong>Conclusions: </strong>HMPV-associated severe pediatric pneumonia in high burden settings was predominantly in young infants and clinically indistinguishable from RSV. HMPV-positives had low case fatality, similar to that in RSV-positives.</p>","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":" ","pages":""},"PeriodicalIF":10.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142567543","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}
引用次数: 0
Interventions targeting the nasal microbiome to eradicate MRSA. 针对鼻腔微生物组的干预措施可根除 MRSA。
IF 10.9 1区 医学
Clinical Microbiology and Infection Pub Date : 2024-10-29 DOI: 10.1016/j.cmi.2024.10.022
Mary T Bessesen
{"title":"Interventions targeting the nasal microbiome to eradicate MRSA.","authors":"Mary T Bessesen","doi":"10.1016/j.cmi.2024.10.022","DOIUrl":"https://doi.org/10.1016/j.cmi.2024.10.022","url":null,"abstract":"<p><strong>Background: </strong>Staphylococcus aureus is an important pathogen in many sites, including bloodstream, skin and soft tissue, bone and joints. When infection is caused by methicillin resistant S. aureus (MRSA) therapy is more difficult and outcomes are less favorable. Nasal colonization is associated with increased risk for MRSA infections. The nasal microbiome may play a role in risk for nasal colonization and infection.</p><p><strong>Objectives: </strong>To review the role of the microbiome in MRSA nasal colonization and infection.</p><p><strong>Sources: </strong>Peer reviewed literature identified in a Medline search using MRSA, S. aureus, prebiotic and microbiota as search terms.</p><p><strong>Content: </strong>Reduction of S. aureus nasal colonization has been shown to reduce risk of S. aureus infections, but decolonization methods are imperfect. The role of the nasal microbiome in host defense against S. aureus colonization and infection is explored. Numerous organisms have been shown to be negatively associated with S. aureus colonization. Antimicrobial molecules produced by these organisms are an active area of research.</p><p><strong>Implications: </strong>Future research should focus on development of safe and effective molecules that can inhibit S. aureus in the nasal vestibule. Damage to the diverse nasal microbiota by unnecessary antibiotics should be avoided.</p>","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":" ","pages":""},"PeriodicalIF":10.9,"publicationDate":"2024-10-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142557319","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}
引用次数: 0
Infectious Diseases Ethics: A Worldwide Survey. 传染病伦理:全球调查。
IF 10.9 1区 医学
Clinical Microbiology and Infection Pub Date : 2024-10-26 DOI: 10.1016/j.cmi.2024.10.021
Elda Righi, Massimo Mirandola, Alessandra Agnese Grossi, Murat Akova, Evelina Tacconelli, Anna Fratucello, Asma Nasim, Aleksandra Barac, Dafna Yahav
{"title":"Infectious Diseases Ethics: A Worldwide Survey.","authors":"Elda Righi, Massimo Mirandola, Alessandra Agnese Grossi, Murat Akova, Evelina Tacconelli, Anna Fratucello, Asma Nasim, Aleksandra Barac, Dafna Yahav","doi":"10.1016/j.cmi.2024.10.021","DOIUrl":"https://doi.org/10.1016/j.cmi.2024.10.021","url":null,"abstract":"<p><strong>Objectives: </strong>COVID-19 unravelled new ethical issues in the neglected field of infectious diseases ethics (IDE). We investigated IDE involvement among ID professionals.</p><p><strong>Methods: </strong>A global survey was disseminated during 2021-2022. Responses were stratified by demographics, WHO region, income, and ethics training. A confirmatory factor analysis (CFA) was used to identify two themes representing IDE relevant areas (Theme 1, including stigma, inequity, vulnerability, public health, and global impact) and emerging topics (Theme 2, including inequity and research integrity in COVID-19, increased ethics interest, and gaps in IDE). Quantile and logistic regression analyses investigated determinants of ethics themes and responders' ethics attitude.</p><p><strong>Results: </strong>We included 477 participants from 71 countries. Most were females (282/460, 61%) and clinicians (327/457, 72%). Participants advocated further personal (289/443, 65%) or societies' (374/450, 83%) involvement in bioethics. Only 5% (22/477) of respondents claimed to have received enough bioethics training and 28% (114/412) were dissatisfied with it. Dedicated courses or expert case discussion were the preferred ways for receiving education in bioethics. Theme 1 and 2 median values were above 7 (on a 1-10 scale), showing high interest in IDE. CFA showed optimal and acceptable fit, respectively. Being from the region of Americas was associated with Theme 1, while having received bioethics training was associated with both themes. Females, respondents trained in bioethics, and those from the Americas and Europe regions reported lower involvement in bioethics activities, while those aged between 44-54 years and trained in bioethics were more involved. Age above 55 years and non-clinical role were negatively associated with aspiration for further bioethics involvement.</p><p><strong>Conclusions: </strong>We identified IDE themes that can inform on gaps in bioethics. Ethics training was associated with interest in IDE and bioethics activities and should be offered to integrate this discipline into daily clinical practice across age, gender, and different areas worldwide.</p>","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":" ","pages":""},"PeriodicalIF":10.9,"publicationDate":"2024-10-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142567546","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}
引用次数: 0
Efficacy and safety of ZX-7101A, an inhibitor of influenza cap-dependent endonuclease, in adults with uncomplicated influenza: a randomised, double-blind, placebo-controlled phase 2/3 Trial. 流感帽依赖性内切酶抑制剂 ZX-7101A 对无并发症流感成人患者的疗效和安全性:随机、双盲、安慰剂对照的 2/3 期试验。
IF 10.9 1区 医学
Clinical Microbiology and Infection Pub Date : 2024-10-26 DOI: 10.1016/j.cmi.2024.10.020
Hongyu Wang, Gang Wang, Yan Gao, Lihong Qu, Hong Wang, Min Deng, Hainv Gao, Yilin Li, Nan Yang, Baogui Wang, Rongge Liu, Xuzhu Ma, Zhen Tao, Guoqiang Zhang, Qian Wang, Weifeng Zhao, Yunsong Yu, Lin Chen, Lianchun Liang, Shengyu Wang, Lei Shao, Tao Yang, JingLei Cao, Yuan Cao, Xiaoli Qin, Jingwen Ai, Huadong Zhu, Wenhong Zhang
{"title":"Efficacy and safety of ZX-7101A, an inhibitor of influenza cap-dependent endonuclease, in adults with uncomplicated influenza: a randomised, double-blind, placebo-controlled phase 2/3 Trial.","authors":"Hongyu Wang, Gang Wang, Yan Gao, Lihong Qu, Hong Wang, Min Deng, Hainv Gao, Yilin Li, Nan Yang, Baogui Wang, Rongge Liu, Xuzhu Ma, Zhen Tao, Guoqiang Zhang, Qian Wang, Weifeng Zhao, Yunsong Yu, Lin Chen, Lianchun Liang, Shengyu Wang, Lei Shao, Tao Yang, JingLei Cao, Yuan Cao, Xiaoli Qin, Jingwen Ai, Huadong Zhu, Wenhong Zhang","doi":"10.1016/j.cmi.2024.10.020","DOIUrl":"https://doi.org/10.1016/j.cmi.2024.10.020","url":null,"abstract":"<p><strong>Objectives: </strong>To evaluate the efficacy and safety of ZX-7101A: an inhibitor of influenza viral cap-dependent endonuclease, in adults with uncomplicated influenza and explore treatment-emergent resistance.</p><p><strong>Methods: </strong>We conducted a randomized, double-blind, placebo-controlled, adaptive-design phase 2 and phase 3 studies (ZX-7101A-202) in adults with uncomplicated influenza. Eligible patients were randomised 1:1:1 to receive a single dose of 40 or 80mg ZX-7101A or placebo, stratified by body weight and baseline composite symptom score. The primary efficacy endpoint was time to alleviation of influenza symptoms (TTAS) in intention-to-treat infected (ITTI) population.</p><p><strong>Results: </strong>The phase 2 trial suggested a significantly shorter in TTAS for ZX-7101A compared to placebo: the median TTAS of 40 or 80mg ZX-7101A was 34.7 hours (95% confidence interval [CI], 22.8-43.4; p=0.005) and 45.8 hours (95%CI, 32.0-66.3; p=0.020), compared with 63.6 hours (95%CI, 43.9-93.4) in the placebo group. In the phase 3 trial, the TTAS of both ZX-7101A dose groups was significantly shortened relative to the placebo: the median TTAS was shortened to 48.4 hours (95%CI, 40.5-55.6) for 40mg and 39.4 hours (95%CI, 35.8-49.3) for 80mg, compared with 62.9 hours (95%CI, 56.4-69.3) for placebo (p=0.003 and p<0.001, respectively). In the safety population, ZX-7101A treatment was associated with fewer adverse events (AEs), with 41.8% (100/239) in the 40mg group, 44.2% (106/240) in the 80mg group, and 53.8% (129/240) in the placebo group. The majority of AEs were mild or moderate. Emergence of resistance to ZX-7101A through I38T amino acid substitution was detected in 5/122 (4.1%) patients.</p><p><strong>Conclusions: </strong>ZX-7101A was an effective treatment for influenza with a single dose of either 40mg or 80mg, with more rapid alleviation of influenza symptoms versus placebo. No safety concerns were identified with single-dose treatment of ZX-7101A.</p>","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":" ","pages":""},"PeriodicalIF":10.9,"publicationDate":"2024-10-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142567538","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}
引用次数: 0
Agreement between Mycobacterium tuberculosis antigen-based skin test and interferon-gamma release assay in elderly individuals aged ≥65 years in China. 中国≥65 岁老年人结核分枝杆菌抗原皮试与干扰素-γ 释放测定之间的一致性。
IF 12.7 1区 医学
Clinical Microbiology and Infection Pub Date : 2024-10-23 DOI: 10.1016/j.cmi.2024.10.016
Yijun He, Lingyu Shen, Jiang Du, Xuefang Cao, Bin Zhang, Dakuan Wang, Boxuan Feng, Zihan Li, Yuanzhi Di, Juanjuan Huang, Tonglei Guo, Jianguo Liang, Jiaoxia Yan, Zisen Liu, Qi Jin, Weitao Duan, Henan Xin, Lei Gao
{"title":"Agreement between Mycobacterium tuberculosis antigen-based skin test and interferon-gamma release assay in elderly individuals aged ≥65 years in China.","authors":"Yijun He, Lingyu Shen, Jiang Du, Xuefang Cao, Bin Zhang, Dakuan Wang, Boxuan Feng, Zihan Li, Yuanzhi Di, Juanjuan Huang, Tonglei Guo, Jianguo Liang, Jiaoxia Yan, Zisen Liu, Qi Jin, Weitao Duan, Henan Xin, Lei Gao","doi":"10.1016/j.cmi.2024.10.016","DOIUrl":"10.1016/j.cmi.2024.10.016","url":null,"abstract":"<p><strong>Objectives: </strong>To determine the agreement of Mycobacterium tuberculosis (MTB) antigen-based skin test (TBST) with interferon-gamma release assay (IGRA) in the elderly individuals aged ≥65 years beyond instruction for use in China.</p><p><strong>Methods: </strong>Based on the baseline survey of a randomized controlled trial with the objective of exploring suitable regimens for tuberculosis(TB) preventive treatment, MTB infection was tested using TBST and IGRA in parallel in rural residents aged 50-70 years using a cross-sectional study design.</p><p><strong>Results: </strong>A total of 21 219 participants with both TBST and IGRA results were included in this analysis. The concordance between TBST and IGRA was 89.4% (95% CI, 89.0-89.8%) with a kappa coefficient of 0.61 (95% CI, 0.60-0.62). In those aged ≥65 years, the concordance was 86.5% (95% CI, 85.6-87.4%) with a kappa coefficient of 0.55 (95% CI, 0.52-0.58). 21.2% (35/165) of the participants with indeterminate IGRA results were TBST positive, and nine of them were aged ≥65 years.</p><p><strong>Discussion: </strong>The consistent agreement between TBST and IGRA in individuals aged ≥65 years suggests that TBST has the potential to be used in the elderly with age beyond instruction for use in China. The respective diagnostic performance of each test will be analysed when the longitudinal data on incident TB is obtained in the future.</p>","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":" ","pages":""},"PeriodicalIF":12.7,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142496343","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}
引用次数: 0
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