Diagnostic performance and antibiotic impact of droplet digital PCR in suspected sepsis: the PROGRESS trial

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. In a multicenter randomized trial of patients with suspected sepsis, droplet digital PCR identified bloodstream pathogens faster and more often than blood culture and guided earlier, better-targeted antibiotics linked to improved survival.

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Journal
Nature Communications
Published
2026-08-20
DOI
https://doi.org/10.1038/s41467-026-76767-y
Primary Topic
Bacterial Identification and Susceptibility Testing
Type
article
Field-Weighted Citation Impact
0.00

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article

Diagnostic performance and antibiotic impact of droplet digital PCR in suspected sepsis: the PROGRESS trial

Qiaoyan Yue, Shuang Xiao, Tingting Su, Hejuan Du et al.
Nature Communications
Bacterial Identification and Susceptibility Testing
article

Diagnostic performance and antibiotic impact of droplet digital PCR in suspected sepsis: the PROGRESS trial

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

Abstract

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. In a multicenter randomized trial of patients with suspected sepsis, droplet digital PCR identified bloodstream pathogens faster and more often than blood culture and guided earlier, better-targeted antibiotics linked to improved survival.

Nature Communications
Central South University (CN), Anhui Medical University (CN), Fudan University (CN), Wenzhou Medical University (CN), XinHua Hospital (CN), First Affiliated Hospital of Wenzhou Medical University (CN), Soochow University (CN), Nanjing Traditional Chinese Medicine Hospital (CN), Ruian People's Hospital (CN), Minhang District Central Hospital (CN), Nanjing Drum Tower Hospital (CN), Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital (CN), Shanghai First People's Hospital (CN), First Affiliated Hospital of Anhui Medical University (CN), Shanghai Sixth People's Hospital (CN), First Affiliated Hospital of Soochow University (CN), Wuxi People's Hospital (CN), Huashan Hospital (CN), Xiangya Hospital Central South University (CN), Nanjing Medical University (CN)
National Natural Science Foundation of China, National Key Research and Development Program of China
Good health and well-being
Openalex Percentile: Top 13%
Bacterial Identification and Susceptibility Testing
DOIOpen Access PDFOpenAlex
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