Haocheng Zhang, Ke Lin, Xinlei Xu, Qiaoyan Yue, Xiang Li, Xiaohua Chen, Liang Hong, Lina Chen, Yan Huang, Ying Ye, Tingting Su, Jingye Pan, Weiqin Li, Shuang Xiao, Xiaoxia Geng, Jingjing Zheng, Lijing Jiang, Jie Chen, Shengguo Zhang, Yadi Liu, Liang Li, Jun Yin, Hejuan Du, Aiming Zhou, Lu Ke, Qiuping Huang, Li Chen, Ting Feng, Ruilan Wang, Jingwen Ai, Wenhong Zhang
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.