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

Fudan University

Status: Completed

Conditions: Septic Shock; Sepsis

Treatments: Diagnostic Test: droplet digital PCR method; Diagnostic Test: blood culture

Study type: Interventional

Funder types: Other

Identifiers

NCT05190861

PROGRESS

Details and patient eligibility

About

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.

Enrollment: 1,032 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1.18 years or older

2.Meet 2 of 4 sepsis criteria

1. Temperature > 38C or < 36C

2. Heart rate > 90 bpm

3. Respiratory rate >20 or PaCO2 <32mmHg

4. WBC >12000/µL or < 4000/µL or > 10% bands

   3.Hospitalized patients who have a diagnostic blood culture ordered as standard of care for suspected sepsis

   4.Informed Consent by patient or legal representative.

   Exclusion Criteria:

   1. Refusal to participate in the study or Failure to comply with treatment or follow-up time
   2. Known breastfeeding or pregnancy
   3. The researcher believes that there are any conditions (social or medical) that allow subjects to participate is unsafe. For example, severe anemia or high risk of bleeding,etc., which are not suitable for taking peripheral blood for testing
   4. Participating in other clinical studies

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1,032 participants in 2 patient groups

droplet digital PCR method

Experimental group

Description:

Pathogen detection by droplet digital PCR method as an adjunct to traditional microbiological assessments including blood culture

Treatment:

Diagnostic Test: droplet digital PCR method

blood culture only

Active Comparator group

Description:

Pathogen detection by microbiological assessments including blood culture

Treatment:

Diagnostic Test: blood culture