Nature communications · 2026
Diagnostic performance and antibiotic impact of droplet digital PCR in suspected sepsis: the PROGRESS trial.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Zhang Haocheng, Lin Ke, Xu Xinlei, Yue Qiaoyan, Li Xiang, Chen Xiaohua, Hong Liang, Chen Lina, Huang Yan, Ye Ying, Su Tingting, Pan Jingye, Li Weiqin, Xiao Shuang, Geng Xiaoxia, Zheng Jingjing, Jiang Lijing, Chen Jie, Zhang Shengguo, Liu Yadi, Li Liang, Yin Jun, Du Hejuan, Zhou Aiming, Ke Lu, Huang Qiuping, Chen Li, Feng Ting, Wang Ruilan, Ai Jingwen, Zhang Wenhong
Аннотация
Currently, tools to dynamically monitor pathogen load and guide antibiotic adjustment in suspected sepsis are limited. In this prospective, multicenter randomized trial (3:1, ddPCR vs standard care), 1,373 patients were followed for 90 days. The primary outcome was diagnostic efficacy; secondary outcomes included mortality and SOFA. ddPCR showed higher detection positivity (54.1% vs 21.6%, p < 2 × 10-16), faster turnaround, and sensitivity of 80.6%. It increased appropriate antimicrobial coverage (12.91% vs 6.1%, p = 0.0039), and sufficient coverage within 0-3 days was associated with improved outcomes (p = 0.026). Baseline pathogen load >3051 copies/mL, day 3 > 404.1 copies/mL, and day 7 > 1348 copies/mL predicted 28-day mortality. Furthermore, ddPCR-guided early, precision-based adjustment of antimicrobial therapy significantly increased the rate of appropriate antimicrobial coverage, thereby translating into a meaningful improvement in survival outcomes among patients with sepsis. ClinicalTrials.gov: NCT05190861.