Clinical Infectious Diseases最新文献

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The burden of all-cause mortality following influenza-associated hospitalizations, FluSurv-NET, 2010-2019. 2010-2019 年流感相关住院后全因死亡率负担,FluSurv-NET。
IF 8.2 1区 医学
Clinical Infectious Diseases Pub Date : 2024-11-04 DOI: 10.1093/cid/ciae547
Alissa C O'Halloran, Alexander J Millman, Rachel Holstein, Sonja J Olsen, Charisse Cummings, Shua J Chai, Pam Daily Kirley, Nisha B Alden, Kimberly Yousey-Hindes, James Meek, Kyle P Openo, Emily Fawcett, Patricia A Ryan, Lauren Leegwater, Justin Henderson, Melissa McMahon, Ruth Lynfield, Kathy M Angeles, Molly Bleecker, Suzanne McGuire, Nancy L Spina, Brenda L Tesini, Maria A Gaitan, Krista Lung, Eli Shiltz, Ann Thomas, H Keipp Talbott, William Schaffner, Mary Hill, Carrie Reed, Shikha Garg
{"title":"The burden of all-cause mortality following influenza-associated hospitalizations, FluSurv-NET, 2010-2019.","authors":"Alissa C O'Halloran, Alexander J Millman, Rachel Holstein, Sonja J Olsen, Charisse Cummings, Shua J Chai, Pam Daily Kirley, Nisha B Alden, Kimberly Yousey-Hindes, James Meek, Kyle P Openo, Emily Fawcett, Patricia A Ryan, Lauren Leegwater, Justin Henderson, Melissa McMahon, Ruth Lynfield, Kathy M Angeles, Molly Bleecker, Suzanne McGuire, Nancy L Spina, Brenda L Tesini, Maria A Gaitan, Krista Lung, Eli Shiltz, Ann Thomas, H Keipp Talbott, William Schaffner, Mary Hill, Carrie Reed, Shikha Garg","doi":"10.1093/cid/ciae547","DOIUrl":"https://doi.org/10.1093/cid/ciae547","url":null,"abstract":"<p><strong>Background: </strong>While the estimated number of U.S. influenza-associated deaths is reported annually, detailed data on the epidemiology of influenza-associated deaths, including the burden of in-hospital versus post-hospital discharge deaths are limited.</p><p><strong>Methods: </strong>Using data from the 2010-11 through 2018-19 seasons from the Influenza Hospitalization Surveillance Network, we linked cases to death certificates to identify patients who died from any cause during their influenza hospital stay or within 30 days post discharge. We described demographic and clinical characteristics of patients who died in hospital versus post discharge and characterized locations and causes of death (COD).</p><p><strong>Results: </strong>Among 121,390 cases hospitalized with laboratory-confirmed influenza over 9 seasons, 5.5% died; 76% of deaths were in patients ≥65 years, 71% were non-Hispanic White, and 34% had ≥4 underlying medical conditions. Among all patients with an influenza-associated hospitalization who died, 48% of deaths occurred after hospital discharge; the median days from discharge to death was 9 days (IQR 3-19 days). Post-discharge deaths more often occurred in older patients and among those with underlying medical conditions. Only 37% of patients who died had \"influenza\" as a COD on their death certificate. Influenza was more frequently listed as a COD among persons who died in-hospital compared with cardiovascular disease among those who died after discharge.</p><p><strong>Conclusions: </strong>All-cause mortality burden is substantial among patients hospitalized with influenza, with almost 50% of deaths occurring within 30 days after hospital discharge. Surveillance systems should consider capture of post-discharge outcomes to better characterize the impact of influenza on all-cause mortality.</p>","PeriodicalId":10463,"journal":{"name":"Clinical Infectious Diseases","volume":null,"pages":null},"PeriodicalIF":8.2,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142567614","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
Relationship between clarithromycin MICs and treatment responses in Mycobacterium avium complex pulmonary disease. 复合分枝杆菌肺病中克拉霉素 MIC 与治疗反应之间的关系。
IF 8.2 1区 医学
Clinical Infectious Diseases Pub Date : 2024-11-04 DOI: 10.1093/cid/ciae546
Joong-Yub Kim, Hyeontaek Hwang, DaHae Yim, Yunhee Choi, Taek Soo Kim, Jake Whang, Nakwon Kwak, Jae-Joon Yim
{"title":"Relationship between clarithromycin MICs and treatment responses in Mycobacterium avium complex pulmonary disease.","authors":"Joong-Yub Kim, Hyeontaek Hwang, DaHae Yim, Yunhee Choi, Taek Soo Kim, Jake Whang, Nakwon Kwak, Jae-Joon Yim","doi":"10.1093/cid/ciae546","DOIUrl":"https://doi.org/10.1093/cid/ciae546","url":null,"abstract":"<p><strong>Background: </strong>Mycobacterium avium complex pulmonary disease (MAC-PD) is a chronic lung condition with rapidly increasing prevalence worldwide. Macrolides like azithromycin and clarithromycin are the backbone of long-term antibiotic therapy for progressive MAC-PD. The impact of minimum inhibitory concentrations (MICs), especially within the susceptible range, for macrolides on treatment responses remains unclear.</p><p><strong>Methods: </strong>We analyzed adult patients who started treatment for MAC-PD between 1 March 2009 and 1 March 2022 at Seoul National University Hospital. Patients were categorized into four groups according to the clarithromycin MICs of their causative strains at treatment initiation. Logistic regression was employed to evaluate the impact of clarithromycin MICs on the microbiological cure rate. Companion drugs and their MICs, alongside clinical characteristics like age, sex, body mass index, cavity presence, acid-fast bacilli smear positivity, causative species, and erythrocyte sedimentation rate were adjusted in multivariable analysis.</p><p><strong>Results: </strong>Four-hundred thirty-six patients (median age, 65 years; 34% men) were included. Microbiological cure rates were 51.8%, 51.9%, 50.0%, and 18.2% for patients with clarithromycin MICs ≤0.5, 1-2, 4-8, and ≥32 µg/mL, respectively (P=0.181). No significant differences in microbiological cure rates were observed across varying levels of clarithromycin MICs within the susceptible range (≤8 µg/mL). Relative to patients with clarithromycin-susceptible strains, patients with MICs ≥32 µg/mL had an odds ratio of 0.25 for achieving microbiological cure (95% confidence interval, 0.06-1.07; P=0.06).</p><p><strong>Conclusions: </strong>Treatment responses were comparable among patients with strains having clarithromycin MICs within the susceptible range, but were likely to be worse for patients with strains having MICs ≥32 µg/mL.</p>","PeriodicalId":10463,"journal":{"name":"Clinical Infectious Diseases","volume":null,"pages":null},"PeriodicalIF":8.2,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142575445","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
Tuberculosis and increased incidence of cardiovascular disease: Cohort study using US and UK health records. 肺结核与心血管疾病发病率的增加:利用美国和英国健康记录进行的队列研究。
IF 8.2 1区 医学
Clinical Infectious Diseases Pub Date : 2024-11-04 DOI: 10.1093/cid/ciae538
Julia A Critchley, Elizabeth S Limb, Anjali Khakharia, Iain M Carey, Sara C Auld, Stephen DeWilde, Tess Harris, Lawrence S Phillips, Derek G Cook, Mary K Rhee, Umar A R Chaudhry, Liza Bowen, Matthew J Magee
{"title":"Tuberculosis and increased incidence of cardiovascular disease: Cohort study using US and UK health records.","authors":"Julia A Critchley, Elizabeth S Limb, Anjali Khakharia, Iain M Carey, Sara C Auld, Stephen DeWilde, Tess Harris, Lawrence S Phillips, Derek G Cook, Mary K Rhee, Umar A R Chaudhry, Liza Bowen, Matthew J Magee","doi":"10.1093/cid/ciae538","DOIUrl":"https://doi.org/10.1093/cid/ciae538","url":null,"abstract":"<p><strong>Background: </strong>Limited evidence suggests elevated risks of cardiovascular disease (CVD) among people diagnosed with tuberculosis (TB) disease, though studies have not adjusted for pre-existing CVD risk. We carried out a cohort study using two separate datasets, estimating CVD incidence in people with TB versus those without.</p><p><strong>Methods: </strong>Using data from the United States (Veterans Health Administration) and the United Kingdom (Clinical Practice Research Datalink) for 2000-2020 we matched adults with incident TB disease and no CVD history 2-years before TB diagnosis (US n=2,121; UK n=15,820) with up to 10 people without TB on the basis of age, sex, race/ethnicity and healthcare practice. Participants were followed beginning 2-years before TB diagnosis and for 2-years subsequently. The acute period was defined as 3-months before/after TB diagnosis. TB, CVD and covariates were identified from electronic routinely collected data (primary and secondary care; mortality). Poisson models estimated incident rate ratios (IRR) for CVD events in people with TB compared to those without.</p><p><strong>Results: </strong>CVD incidence was consistently higher in people with TB, including during the baseline period (pre-TB) and particularly in the acute period: IRRs were US 3.5 (95% Confidence Interval 2.7-4.4), UK 2.7 (2.2-3.3). Rate Ratios remained high after adjusting for differences in pre-existing CVD risk: US 3.2 (2.2-4.4), UK 1.6 (1.2-2.1).</p><p><strong>Conclusion: </strong>Increased CVD incidence was observed in people with TB versus those without, especially within months of TB diagnosis, persistent after adjustment for differences in pre-existing risk. Enhancing CVD screening and risk management may improve long-term outcomes in people with TB.</p>","PeriodicalId":10463,"journal":{"name":"Clinical Infectious Diseases","volume":null,"pages":null},"PeriodicalIF":8.2,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142575447","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
Five-year evaluation of Anal Cancer Screening Program in Men Who Have Sex With Men with HIV at Two Academic Center Clinics. 在两家学术中心诊所开展的男男性行为者艾滋病病毒感染者肛门癌筛查项目五年评估。
IF 8.2 1区 医学
Clinical Infectious Diseases Pub Date : 2024-11-04 DOI: 10.1093/cid/ciae541
Amit C Achhra, Elizabeth Chan, Serina Applebaum, Maggie Guerrero, Ritche Hao, Haddon Pantel, Michael Virata, Margaret Fikrig, Lydia Barakat
{"title":"Five-year evaluation of Anal Cancer Screening Program in Men Who Have Sex With Men with HIV at Two Academic Center Clinics.","authors":"Amit C Achhra, Elizabeth Chan, Serina Applebaum, Maggie Guerrero, Ritche Hao, Haddon Pantel, Michael Virata, Margaret Fikrig, Lydia Barakat","doi":"10.1093/cid/ciae541","DOIUrl":"https://doi.org/10.1093/cid/ciae541","url":null,"abstract":"<p><strong>Background: </strong>Guidelines recommend annual anal cytology-based squamous cell carcinoma of anus (SCCA) screening for men who have sex with men (MSM) with HIV aged ≥35 years (eligible population). Recommended threshold for high resolution anoscopy (HRA) depends on its availability: low-threshold (any abnormal cytology) if availability is high, and high-threshold (High-Grade Squamous Intraepithelial Lesion (HSIL) on cytology) if availability is low.</p><p><strong>Methods: </strong>Retrospective chart review (2018-2022) at academic HIV clinics. We evaluate (i) 5-year uptake of cytology based SCCA screening in eligible population; (ii) estimate HSIL detection rate based on our current low-threshold criteria, and if high-threshold criteria were used for HRA referral.</p><p><strong>Results: </strong>Of 432 eligible individuals, only 219 (50.7%) had at least one, and only 113 (26%) had >1 SCCA screening tests in a median followup of 4 years. N=74 (17.1%) of individuals had at least one abnormal anal cytology during follow-up, of which 56 (75.6%) received HRA. Increasing age (≥57 years) and history of smoking negatively correlated with ever receiving screening. Anal cytology (365 tests in 206 individuals) showed: 17.5% 'unsatisfactory', and 26.8% with any abnormal cytology (zero with HSIL) triggering HRA referral. Only 34 individuals (7.8% of screening eligible) were ever detected with HSIL. Strictly using high-threshold criterion for HRA referral would have led to no HRA or HSIL detection.</p><p><strong>Conclusions: </strong>We noted poor uptake of screening over time, particularly in older age groups. Importantly, anal cytology performed poorly as a triage test for HRA referral: high rates of 'unsatisfactory' samples and low sensitivity for detecting HSIL.</p>","PeriodicalId":10463,"journal":{"name":"Clinical Infectious Diseases","volume":null,"pages":null},"PeriodicalIF":8.2,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142567611","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
Switch to Integrase Strand Transfer Inhibitors during the Menopausal Transition is Associated with Accelerated Body Composition Change in Women with HIV. 感染 HIV 的女性在更年期转用整合酶链转移抑制剂与身体成分的加速变化有关。
IF 8.2 1区 医学
Clinical Infectious Diseases Pub Date : 2024-11-04 DOI: 10.1093/cid/ciae540
Rebecca A Abelman, Yifei Ma, C Christina Mehta, Qian Yang, Fan Xia, James B Brock, Maria Alcaide, Anjali Sharma, Michelle Floris-Moore, Elizabeth Topper, Kathleen M Weber, Seble G Kassaye, Deborah Gustafson, Carl Grunfeld, Cecile D Lahiri, Phyllis C Tien
{"title":"Switch to Integrase Strand Transfer Inhibitors during the Menopausal Transition is Associated with Accelerated Body Composition Change in Women with HIV.","authors":"Rebecca A Abelman, Yifei Ma, C Christina Mehta, Qian Yang, Fan Xia, James B Brock, Maria Alcaide, Anjali Sharma, Michelle Floris-Moore, Elizabeth Topper, Kathleen M Weber, Seble G Kassaye, Deborah Gustafson, Carl Grunfeld, Cecile D Lahiri, Phyllis C Tien","doi":"10.1093/cid/ciae540","DOIUrl":"https://doi.org/10.1093/cid/ciae540","url":null,"abstract":"<p><strong>Background: </strong>Integrase strand transfer inhibitors (INSTIs) and the menopausal transition have separately been associated with body composition changes in women with HIV (WWH), but their interaction is unknown.</p><p><strong>Methods: </strong>From 2006-2019, 1131 non-pregnant WWH with viral suppression [(419 who switched to INSTI (INSTI+); 712 who did not switch (INSTI-)] and 887 women without HIV (WWOH) from the Women's Interagency HIV Study were included. Mixed effect models were used to evaluate change in waist circumference (WC) and BMI by menopausal phase defined using anti-Müllerian hormone, a biomarker of ovarian reserve.</p><p><strong>Results: </strong>During premenopause, WWH had increases in WC (INSTI+: 0.01cm per 6 month (mo); 95%CI:-0.29,0.32 and INSTI-: 0.22cm per 6mo;95%CI:-0.01,0.44) that were not statistically significantly different from WWOH; there was also little difference by INSTI status. In late perimenopause, INSTI+ had faster increases in WC (0.37cm per 6mo;95%CI:0.15,0.60) while INSTI- had smaller increases (0.14cm per 6mo;95%CI:-0.06,0.34) compared to WWOH. In menopause, INSTI+ had faster increases peaking at 43mo then declining while INSTI- had smaller increases (0.14cm per 6mo;95%CI:-0.02,0.30). Compared to INSTI-, in late perimenopause, INSTI+ had 0.26 cm per 6mo (95%CI:0.02,0.50) faster linear increases in WC and in menopause, INSTI+ was associated with faster increases peaking at 41mo. BMI trajectories were similar to WC in late peri- and menopausal women.</p><p><strong>Conclusions: </strong>Switching to an INSTI-based regimen during late peri- and menopause is associated with faster increases in WC and BMI when compared to women who did not switch. Menopausal status should be considered when switching to an INSTI.</p>","PeriodicalId":10463,"journal":{"name":"Clinical Infectious Diseases","volume":null,"pages":null},"PeriodicalIF":8.2,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142575446","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
Current and future strategies for the prevention and treatment of cytomegalovirus infections in transplantation. 预防和治疗移植手术中巨细胞病毒感染的当前和未来策略。
IF 8.2 1区 医学
Clinical Infectious Diseases Pub Date : 2024-11-04 DOI: 10.1093/cid/ciae535
Madeleine R Heldman, Michael J Boeckh, Ajit P Limaye
{"title":"Current and future strategies for the prevention and treatment of cytomegalovirus infections in transplantation.","authors":"Madeleine R Heldman, Michael J Boeckh, Ajit P Limaye","doi":"10.1093/cid/ciae535","DOIUrl":"https://doi.org/10.1093/cid/ciae535","url":null,"abstract":"<p><p>Successful prevention and treatment of cytomegalovirus (CMV) infection remains a central focus of clinical care in solid organ and allogeneic hematopoietic cell transplantation. Over the past 5 years, pivotal clinical trials have created new paradigms in CMV prevention, including diverging approaches in HCT and SOT. We review recent advances in CMV risk assessment and progress in antiviral and immune-based strategies for CMV prevention and treatment. We highlight approaches to optimize CMV-specific immunity through vaccination, monoclonal antibodies, and virus-specific T-cells. Observational studies and interventional trials of commercially-available CMV cell-mediated immunity assays for refining preventive and treatment strategies are summarized. Finally, we discuss the importance of enhancing CMV-specific immunity to mitigate the negative impacts of CMV in different transplant settings. CMV infections in recipients of chimeric antigen receptor-T (CAR-T) cell therapies and other immunocompromised populations are growing areas of importance that are beyond the scope of this review.</p>","PeriodicalId":10463,"journal":{"name":"Clinical Infectious Diseases","volume":null,"pages":null},"PeriodicalIF":8.2,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142567605","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
High Retention and Adherence with Rapid Long-Acting Injectable PrEP Implementation in an Urban Safety-Net Clinic Population. 在城市安全网诊所人群中实施快速长效注射 PrEP 后,保留率和坚持率都很高。
IF 8.2 1区 医学
Clinical Infectious Diseases Pub Date : 2024-11-01 DOI: 10.1093/cid/ciae531
Matthew A Spinelli, Ezra Bisom-Rapp, Megan J Heise, Christina Camp, Ayesha Appa, Albert Y Liu, Kevin Sassaman, Mary Shiels, Francis Mayorga-Munoz, Anthonia Chimezie, Janet Nguyen, Jon Oskarsson, Monica Gandhi
{"title":"High Retention and Adherence with Rapid Long-Acting Injectable PrEP Implementation in an Urban Safety-Net Clinic Population.","authors":"Matthew A Spinelli, Ezra Bisom-Rapp, Megan J Heise, Christina Camp, Ayesha Appa, Albert Y Liu, Kevin Sassaman, Mary Shiels, Francis Mayorga-Munoz, Anthonia Chimezie, Janet Nguyen, Jon Oskarsson, Monica Gandhi","doi":"10.1093/cid/ciae531","DOIUrl":"https://doi.org/10.1093/cid/ciae531","url":null,"abstract":"<p><p>In a low-barrier long-acting PrEP program in a safety-net setting, permitting same-day or next-day initiation, 85% of injections were on-time, and six-month retention was 83%, surpassing outcomes from most previously-reported oral PrEP studies. With drop-in, wrap-around services, similar retention among housing-insecure populations was seen. Long-acting PrEP expansion is urgently needed.</p>","PeriodicalId":10463,"journal":{"name":"Clinical Infectious Diseases","volume":null,"pages":null},"PeriodicalIF":8.2,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142557328","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
Virologic Response and Safety of Ibuzatrelvir, a Novel SARS-CoV-2 Antiviral, in Adults With COVID-19 新型 SARS-CoV-2 抗病毒药物 Ibuzatrelvir 在 COVID-19 成人患者中的病毒学反应和安全性
IF 11.8 1区 医学
Clinical Infectious Diseases Pub Date : 2024-11-01 DOI: 10.1093/cid/ciae529
Mahta Mortezavi, Abigail Sloan, Ravi Shankar P Singh, Luke F Chen, Jin Hyang Kim, Negin Shojaee, Sima S Toussi, John Prybylski, Mary Lynn Baniecki, Arthur Bergman, Anindita Banerjee, Charlotte Allerton, Negar Niki Alami
{"title":"Virologic Response and Safety of Ibuzatrelvir, a Novel SARS-CoV-2 Antiviral, in Adults With COVID-19","authors":"Mahta Mortezavi, Abigail Sloan, Ravi Shankar P Singh, Luke F Chen, Jin Hyang Kim, Negin Shojaee, Sima S Toussi, John Prybylski, Mary Lynn Baniecki, Arthur Bergman, Anindita Banerjee, Charlotte Allerton, Negar Niki Alami","doi":"10.1093/cid/ciae529","DOIUrl":"https://doi.org/10.1093/cid/ciae529","url":null,"abstract":"Background Despite effective vaccines and treatments for COVID-19, clinical burden persists. An unmet need exists for additional effective agents with safety profiles allowing use across a broad population. Ibuzatrelvir is an orally bioavailable SARS-CoV-2 Mpro inhibitor that has demonstrated in vitro antiviral activity and low potential for safety concerns, including drug-drug interactions. Methods This phase 2b, double-blind, randomized clinical trial enrolled US adults aged 18‒&amp;lt;65 years with symptomatic COVID-19 and no risk factors for severe disease. Participants were randomized 1:1:2:2 to receive 100, 300, or 600 mg ibuzatrelvir or placebo orally twice daily for 5 days. Nasopharyngeal specimens were collected on Days 1 (baseline), 3, 5, 10, 14, and 21; adverse events (AEs) were recorded through Day 33. The primary endpoint was change in SARS-CoV-2 RNA level (viral load [VL]) from baseline to Day 5 among participants with baseline VL ≥4 log10 copies/mL. Results Of 240 enrollees, 237 received ≥1 dose and 199 were included in the primary analysis. Placebo-adjusted least squares mean (80% CI) change from baseline in VL at Day 5 was significant across all doses: 100 mg, ‒0.7 (‒1.1, ‒0.3) log10 copies/mL, P=0.02; 300 mg, ‒0.8 (‒1.3, ‒0.3) log10 copies/mL, P=0.01; and 600 mg, ‒1.2 (‒1.5, ‒0.8) log10 copies/mL, P&amp;lt;0.0001. AEs occurred in similar percentages of participants across groups. No deaths from any cause or treatment-related serious AEs occurred through Day 33, and no participants reported dysgeusia. Conclusions All 3 ibuzatrelvir doses were associated with robust antiviral activity and an acceptable safety profile, supporting continued clinical development. Trial Registration Clinicaltrials.gov identifier: NCT05799495","PeriodicalId":10463,"journal":{"name":"Clinical Infectious Diseases","volume":null,"pages":null},"PeriodicalIF":11.8,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142563070","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
Evidence-Informed Provision of Doxycycline Post-Exposure Prophylaxis for Prevention of Bacterial Sexually Transmitted Infections. 根据证据提供强力霉素暴露后预防疗法以预防细菌性传播感染。
IF 8.2 1区 医学
Clinical Infectious Diseases Pub Date : 2024-10-30 DOI: 10.1093/cid/ciae527
Julia C Dombrowski, Deborah Donnell, Cole Grabow, Stephanie E Cohen, Chase A Cannon, Clare E Brown, Susan P Buchbinder, Connie Celum, Anne F Luetkemeyer
{"title":"Evidence-Informed Provision of Doxycycline Post-Exposure Prophylaxis for Prevention of Bacterial Sexually Transmitted Infections.","authors":"Julia C Dombrowski, Deborah Donnell, Cole Grabow, Stephanie E Cohen, Chase A Cannon, Clare E Brown, Susan P Buchbinder, Connie Celum, Anne F Luetkemeyer","doi":"10.1093/cid/ciae527","DOIUrl":"https://doi.org/10.1093/cid/ciae527","url":null,"abstract":"<p><p>Doxycycline post-exposure prophylaxis (doxy-PEP) reduces the risk of bacterial sexually transmitted infections (STIs) among men who have sex with men and transgender women. In the United States, doxy-PEP is in an early stage of integration into clinical practice, and national guidelines for its use were recently released. The goal of this manuscript is to provide practical guidance for clinicians who are considering or currently prescribing doxy-PEP. We address five clinical questions using post hoc analyses of data from the DoxyPEP randomized controlled trial and discuss the potential implications and limitations of each question with the goal of informing clinical practice and implementation of doxy-PEP programs. The questions address patient eligibility criteria for doxy-PEP, the expected benefit and associated doxy-PEP doses for the average patient, the initial number of doses prescribed, and laboratory monitoring of persons taking doxy-PEP.</p>","PeriodicalId":10463,"journal":{"name":"Clinical Infectious Diseases","volume":null,"pages":null},"PeriodicalIF":8.2,"publicationDate":"2024-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142544041","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
Interferon-Gamma Release Assay Conversion and Reversion Reactions During Solid Organ Transplant Evaluation. 实体器官移植评估过程中的干扰素-伽马释放测定转换和逆转反应。
IF 8.2 1区 医学
Clinical Infectious Diseases Pub Date : 2024-10-30 DOI: 10.1093/cid/ciae525
Chia-Yu Chiu, Maryam Mahmood, Lisa M Brumble, Holenarasipur R Vikram, Elitza S Theel, Elena Beam
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