MedTrace Logo

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

NCT05190861 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1032

Last updated 2025-07-11

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Huashan Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-29
Primary Completion
2023-12-29
Completion
2023-12-29

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05190861 on ClinicalTrials.gov