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

N/ACompletedNCT05190861

Huashan Hospital1,032 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

1,032

Conditions

Sepsis Septic Shock

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (9)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Xiangya Hospital Central South University

Changsha, Hunan, China

Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine

Nanjing, Jiangsu, China

Wuxi No.5 People's Hospital

Wuxi, Jiangsu, China

Xinhua Hospital Affliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, China

Minhang Branch of Ruijin Hospital

Shanghai, Shanghai Municipality, China

Zhejiang Rui'an People's Hospital

Rui’an, Zhejiang, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Outcomes

Primary Outcomes

Sensitivity

The primary endpoint of estimated sensitivity will be determined by comparing positive blood culture results with the concomitantly collected ddPCR results from the prospective clinical specimens.

Time frame: Up to 96 hours post blood collection

Specificity

The primary endpoint of estimated specificity will be determined by comparing negative blood culture results with the concomitantly collected ddPCR results from the prospective clinical specimens.

Time frame: Up to 96 hours post blood collection

Secondary Outcomes

Time to the change to the targeted antimicrobial therapy

Time frame: At time point of change to the targeted antimicrobial therapy, up to 96 hours post blood collection

Number of patients with targeted antimicrobial therapy