NCT05190861

Evaluation of Droplet Digital PCR Rapid Detection Method and Precise Diagnosis and Treatment for Suspected Sepsis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,032 (actual)
• Sponsor: Huashan Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Sepsis is a significant public health concern worldwide, with high morbidity and mortality. With regard to a targeted antimicrobial treatment strategy, the earliest possible pathogen detection is of crucial importance. Until now, culture-based detection methods represent the diagnostic gold standard, although they are characterized by numerous limitations. Culture-independent molecular diagnostic procedures may represent a promising alternative. In particular, droplet digital PCR (ddPCR) is a novel one-step PCR assay that achieves higher accuracy and sensitivity in detecting causing pathogens in patients with bloodstream infections.

Conditions

• Sepsis
• Septic Shock

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	droplet digital PCR method	The droplet digital PCR method can detect nucleic acids from the most common pathogens (approximately 90%) responsible for BSIs according to Chinet2020 and takes about 4 hours to perform, reporting within the first 24h of suspected sepsis/septic shock.
DIAGNOSTIC_TEST	blood culture	Blood culture is a conventional microbiological method of pathogen detection. Results from blood cultures are usually not available until 24 to 72 hours after sampling.

Timeline

• Start date: 2021-12-29
• Primary completion: 2023-12-29
• Completion: 2023-12-29
• First posted: 2022-01-13
• Last updated: 2025-07-11

Locations

9 sites across 1 country: China