评价液滴数字 PCR 快速检测方法及疑似脓毒症精准诊断和治疗（PROGRESS）：一项多中心实用型随机对照临床试验研究方案。
Evaluation of droplet digital PCR rapid detection method and precise diagnosis and treatment for suspected sepsis (PROGRESS): a study protocol for a multi-center pragmatic randomized controlled trial.
机构信息
Department of Infectious Diseases, National Medical Center for Infectious Diseases, Shanghai Key Laboratory of Infectious Diseases and Biosafety Emergency Response, Huashan Hospital, Fudan University, Shanghai, China.
Department of Infectious Diseases, The Nanjing Hospital of Chinese Medicine, Affiliated to Nanjing University of Chinese Medicine, Nanjing, Jiangsu, China.
出版信息
BMC Infect Dis. 2022 Jul 19;22(1):630. doi: 10.1186/s12879-022-07557-2.
BACKGROUND
Sepsis is still a major public health concern and a medical emergency due to its high morbidity and mortality. Accurate and timely etiology diagnosis is crucial for sepsis management. As an emerging rapid and sensitive pathogen detection tool, digital droplet PCR (ddPCR) has shown promising potential in rapid identification of pathogens and antimicrobial resistance genes. However, the diagnostic value and clinical impact of ddPCR tests remains to be studied in patients with suspected sepsis. PROGRESS trial is aimed to evaluate the clinical effectiveness of a novel ddPCR assay compared with standard practice.
METHODS
PROGRESS is a multicenter, open-label, pragmatic randomized controlled trial (pRCT) set in ten hospitals, including departments of infectious disease and intensive care units. In this study, a total of 2292 patients with suspected sepsis will be randomly assigned to two arms: the ddPCR group and the control group with a ratio of 3:1. The primary outcome is the diagnostic efficacy, that is, the sensitivity and specificity of the ddPCR assay compared with the synchronous blood culture. Secondary outcomes include the mortality rates and the mean Sequential Organ Failure Assessment (SOFA) score at follow-up time points, the length of stay in the hospital, the time to directed antimicrobial therapy, duration of broad-spectrum antibiotic use, and the EQ-5D-5L score on day 90.
DISCUSSION
It is the first multicenter pragmatic RCT to explore the diagnostic efficacy and clinical impact of the ddPCR assay in patients with suspected sepsis, taking advantage of both RCT's ability to establish causality and the feasibility of pragmatic approaches in real-world studies (RWS). This trial will help us to get a comprehensive view of the assay's capacity for precise diagnosis and treatment of sepsis. It has the potential to monitor the pathogen load change and to guide the antimicrobial therapy, making a beneficial impact on the prognosis of sepsis patients.
TRIAL REGISTRATION
ClinicalTrial.gov, NCT05190861. Registered January 13, 2022-'Retrospectively registered', https://clinicaltrials.gov/ct2/show/NCT05190861 .
背景
由于其高发病率和死亡率，脓毒症仍然是一个主要的公共卫生关注点和医疗急救。准确和及时的病因诊断对于脓毒症的管理至关重要。作为一种新兴的快速而敏感的病原体检测工具，数字液滴 PCR（ddPCR）在快速识别病原体和抗菌药物耐药基因方面显示出了有前景的潜力。然而，ddPCR 检测在疑似脓毒症患者中的诊断价值和临床影响仍有待研究。PROGRESS 试验旨在评估与标准实践相比，一种新型 ddPCR 检测的临床效果。
方法
PROGRESS 是一项多中心、开放标签、实用随机对照试验（pRCT），在 10 家医院进行，包括感染科和重症监护病房。在这项研究中，共有 2292 名疑似脓毒症患者将被随机分配到两组：ddPCR 组和对照组，比例为 3:1。主要结局是诊断效果，即 ddPCR 检测与同步血培养相比的敏感性和特异性。次要结局包括随访时间点的死亡率和平均序贯器官衰竭评估（SOFA）评分、住院时间、定向抗菌治疗时间、广谱抗生素使用时间以及第 90 天的 EQ-5D-5L 评分。
讨论
这是第一项探索 ddPCR 检测在疑似脓毒症患者中的诊断效果和临床影响的多中心实用 RCT，利用 RCT 建立因果关系的能力和实用方法在真实世界研究（RWS）中的可行性。这项试验将帮助我们全面了解该检测方法对脓毒症的精确诊断和治疗能力。它有可能监测病原体负荷的变化，并指导抗菌治疗，对脓毒症患者的预后产生有益的影响。
试验注册
ClinicalTrials.gov，NCT05190861。注册日期：2022 年 1 月 13 日-“回溯性注册”，https://clinicaltrials.gov/ct2/show/NCT05190861。
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