Ma Lin-Lu, Qiu Yang, Song Mei-Na, Chen Yun, Qu Jian-Xin, Li Bing-Hui, Zhao Ming-Juan, Liu Xin-Can
Department of Cardiology, First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Zhengzhou, China.
Center for Evidence-Based and Translational Medicine, Henan University of Traditional Chinese Medicine, Zhengzhou, China.
Front Pharmacol. 2019 Jul 5;10:757. doi: 10.3389/fphar.2019.00757. eCollection 2019.
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. 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. 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. 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.
临床试验是证据的来源。ClinicalTrials.gov对于分析当前状况很有价值。到目前为止，心脏感染的药物干预状况尚不清楚。本研究的目的是全面评估心脏相关感染试验的特征以及药物干预的现状。利用ClinicalTrials.gov网站获取截至2019年2月16日所有已注册的关于心脏相关感染药物干预的临床试验。收集所有注册研究，无论其招募状态、研究结果和研究类型如何。对这些试验的注册信息、结果及网络链接出版物进行分析。共评估了45项符合条件的试验，其中86.7%的试验于2008年或之后开始，91.1%采用干预性研究设计。在所有试验中，35.6%已完成，15.6%已终止。此外，62.2%的干预性临床试验招募了100多名受试者。同时，86.7%的符合条件的试验仅纳入成年受试者。在干预试验中，65.8%处于三期或四期；78.1%采用随机平行分组，分为两组；53.6%采用盲法，61.0%描述了治疗方法。此外，41.5%的试验在北美进行，29.3%在欧洲进行。40.0%的研究赞助商来自行业。此外，48.9%的试验提到了监测委员会的信息，24.4%已在线发表，13.3%已上传其结果。治疗药物主要包括抗生素，其中糖肽类、β-内酰胺类和脂肽类是实验组中研究最常见的抗生素，前两者更为常见。此外，16.2%的试验评估了新型抗菌药物。ClinicalTrials.gov上注册的大多数心脏相关感染临床试验是用于治疗的干预性随机对照试验（RCT）。试验中关注的大多数药物是旧抗生素，很少有试验报告有效结果。有必要加强对结果改善的监督，并将抗菌活性与给药方案相结合以实现最佳临床结果。
