Table_1_Clinical Trial Registration and Reporting: Drug Therapy and Prevention of Cardiac-Related Infections.xlsx

Objective: Clinical trials are the source of evidence. ClinicalTrials.gov is valuable for analyzing current conditions. Until now, the state of drug interventions for heart infections is unknown. The purpose of this study was to comprehensively assess the characteristics of trials on cardiac-related infections and the status of drug interventions.
Methods: The website ClinicalTrials.gov was used to obtain all registered clinical trials on drug interventions for cardiac-related infections as of February 16, 2019. All registration studies were collected, regardless of their recruitment status, research results, and research type. Registration information, results, and weblink-publications of those trials were analyzed.
Results: A total of 45 eligible trials were evaluated and 86.7% of them began from or after 2008 while 91.1% of them adopted interventional study design. Of all trials, 35.6% were completed and 15.6% terminated. Besides, 62.2% of interventional clinical trials recruited more than 100 subjects. Meanwhile, 86.7% of the eligible trials included adult subjects only. Of intervention trials, 65.8% were in the third or fourth phase; 78.1% adopted randomized parallel assignment, containing two groups; 53.6% were masking, and 61.0% described treatment. Moreover, 41.5% of the trials were conducted in North America while 29.3% in Europe. Sponsors for 40.0% of the studies were from the industry. Furthermore, 48.9% of the trials mentioned information on monitoring committees, 24.4% have been published online, and 13.3% have uploaded their results. Drugs for treatments mainly contained antibiotics, among which glycopeptides, β-lactams, and lipopeptides were the most commonly studied ones in experimental group, with the former ones more common. Additionally, 16.2% of the trials evaluated new antimicrobials.
Conclusions: Most clinical trials on cardiac-related infections registered at ClinicalTrials.gov were interventional randomized controlled trials (RCTs) for treatment. Most drugs focused in trials were old antibiotics, and few trials reported valid results. It is necessary to strengthen supervision over improvements in results, and to combine antibacterial activity with drug delivery regimens to achieve optimal clinical outcomes.

【研究目标】临床试验是循证医学的证据来源。临床试验注册平台（ClinicalTrials.gov）是分析当前临床研究现状的重要资源。截至目前，针对心脏感染的药物干预研究现状仍不明晰。本研究旨在全面评估心脏相关感染临床试验的特征及药物干预的开展情况。
【研究方法】本研究检索了截至2019年2月16日ClinicalTrials.gov平台上所有已注册的心脏相关感染药物干预临床试验，无论其招募状态、研究结果及研究类型，均纳入收集范围。随后对这些试验的注册信息、研究结果及关联发表文献的链接进行了分析。
【研究结果】本研究共纳入45项符合纳入标准的临床试验进行分析。其中86.7%的试验启动于2008年及之后，91.1%采用了干预性研究设计。所有试验中，35.6%已完成，15.6%已终止。此外，62.2%的干预性临床试验招募受试者超过100例；86.7%的入选试验仅纳入成年受试者。在干预性试验中，65.8%处于Ⅲ期或Ⅳ期；78.1%采用含2组的随机平行分组设计；53.6%设置了设盲方案；61.0%明确描述了治疗方案。另有41.5%的试验在北美开展，29.3%在欧洲开展；40.0%的研究资助方来自企业。此外，48.9%的试验提及了监查委员会相关信息，24.4%的试验已在线发表，13.3%的试验上传了研究结果。治疗用药物以抗生素为主，试验组中最常研究的类别为糖肽类（glycopeptides）、β-内酰胺类（β-lactams）与脂肽类（lipopeptides）抗菌药物，其中糖肽类应用更为广泛。另有16.2%的试验评估了新型抗菌药物。
【研究结论】在ClinicalTrials.gov平台注册的心脏相关感染临床试验中，多数为治疗用干预性随机对照试验（RCTs）。试验中涉及的药物多为传统抗生素，且仅有少数试验报告了有效的研究结果。未来需加强对试验结果报告完善性的监管，并将抗菌活性与给药方案相结合，以实现最优的临床结局。