Table_1_Registered Interventional Clinical Trials for Old Populations With Infectious Diseases on ClinicalTrials.gov: A Cross-Sectional Study.docx

BackgroundInterventional clinical trials for infectious diseases in old population have arisen much attention in recent years, however, little is known about the characteristics of registered clinical trials regarding this field. This study aimed to investigate the characteristics of registered interventional trials for infectious diseases in old populations on ClinicalTrials.gov.MethodsA cross-sectional study was performed. We used viral OR bacterial OR fungal OR parasitic OR infectious disease to search the ClinicalTrials.gov database and to assess characteristics of included trials. The age of participants was restricted to more than 65 years old. All analyses were performed using the SPSS19.0 software.ResultsA total of 138 registered trials were included. Among them, 105(76.1%) trials were completed; however, the results were available in ClinicalTrials.gov for only 44(31.9%) trials. North America was the most frequently identified study location (52.9%), followed by Europe (30.4%) and Asia (11.6%). Seventy-one percent trials focused on viral pathogens, followed by bacterial pathogens (22.5%). A total of 84.1% trials were prevention oriented. A total of 84.1% trials used randomization, 73.2% trials used parallel assignment, and 64.5% used masking. Eighty-six trials were industry-funded and 52 were non-industry-funded. Industry-funded trials had higher percentages than non-industry-funded trials in available results, prevention trial, and phase 2 and phase 3 trial, and lager sample size trial. One hundred eleven trials were vaccine trials and 27 trials were non-vaccine trials. Vaccine trials had higher percentages than non-vaccine trials in available results, leading industry sponsor and viral etiology.ConclusionsThe current study is the first study of the landscape of interventional clinical trials for infectious diseases in old populations registered in ClinicalTrials.gov, providing the basis for treatment and prevention of infectious diseases in old populations. Trials in this field are still relatively lacking, and additional and better trials are needed.

近年来，针对老年人群感染性疾病干预性临床试验备受关注，然而，关于该领域注册临床试验的特征了解甚少。本研究旨在探究ClinicalTrials.gov上注册的针对老年人群感染性疾病干预性临床试验的特征。方法：进行了一项横断面研究。我们使用病毒或细菌或真菌或寄生虫或感染性疾病作为关键词搜索ClinicalTrials.gov数据库，并评估纳入试验的特征。受试者年龄限制在65岁以上。所有分析均使用SPSS19.0软件进行。结果：共纳入138项注册试验。其中，105项（76.1%）试验已完成；然而，只有44项（31.9%）试验的结果在ClinicalTrials.gov上可查。北美是最常见的试验地点（52.9%），其次是欧洲（30.4%）和亚洲（11.6%）。71%的试验聚焦于病毒病原体，其次是细菌病原体（22.5%）。共计84.1%的试验具有预防导向。84.1%的试验采用随机化方法，73.2%的试验采用平行分组，64.5%的试验采用盲法。86项试验由产业资助，52项由非产业资助。产业资助的试验在结果可用性、预防性试验、2期和3期试验以及大样本量试验方面的比例高于非产业资助的试验。111项试验为疫苗试验，27项为非疫苗试验。疫苗试验在结果可用性、产业资助和病毒病因方面的比例高于非疫苗试验。结论：本研究是首个关于ClinicalTrials.gov上注册的老年人群感染性疾病干预性临床试验格局的研究，为老年人群感染性疾病的防治提供了基础。该领域的临床试验仍相对匮乏，需要更多和更高质量的试验。