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

Not Applicable

• Conditions: Septic Shock; Sepsis
• Interventions: Diagnostic Test: blood culture; Diagnostic Test: droplet digital PCR method

• Registration Number: NCT05190861
• Lead Sponsor: Huashan Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-25
• Study Start: 2021-11-29
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-12
• Last Update Submitted: 2022-01-12
• Study First Posted: 2022-01-13
• Last Update Posted: 2022-01-13
• Primary Completion: 2022-12-01
• Study Completion: 2023-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Sensitivity	Up to 96 hours post blood collection	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.
Specificity	Up to 96 hours post blood collection	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.

Secondary Outcome Measures

Name	Time	Method
Ventilation duration in ICU (hours)	Up to the end of study participation, an average of 1 year
Duration of antimicrobials	Up to the end of study participation, an average of 1 year
Days in hospital (from study inclusion)	Up to the end of study participation, an average of 1 year
Treatment costs	Up to the end of study participation, an average of 1 year
Change in condition severity	Up to the end of study participation, an average of 1 year	The sequential organ failure assessment score (SOFA score), previously known as the sepsis-related organ failure assessment score, higher scores mean worse outcome.
Time to the change to the targeted antimicrobial therapy	At time point of change to the targeted antimicrobial therapy, up to 96 hours post blood collection
Number of patients with targeted antimicrobial therapy	Up to the end of study participation, an average of 1 year
Time to identification of a potential pathogen	At time point of identification of a potential pathogen, up to 96 hours post blood collection
Days in intensive care unit (ICU)	Up to the end of study participation, an average of 1 year
All-cause death	Up to the end of study participation, an average of 1 year
Quality of life of survivors after being discharged	Up to the end of study participation, an average of 1 year	EQ-5D, a standardised measure of health-related quality of life developed by the EuroQol Group.The EQ-5D descriptive system comprises five dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. The number of levels in these dimensions is 5 in the EQ-5D-5L. Higher levels mean worse health states.

Trial Locations

Locations (9)

Shanghai Sixth People's Hospital; 🇨🇳 Shanghai, Shanghai, China

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, China

Zhejiang Rui'an People's Hospital; 🇨🇳 Rui'an, Zhejiang, China

Minhang Branch of Ruijin Hospital; 🇨🇳 Shanghai, Shanghai, China

The First Affiliated Hospital of Wenzhou Medical University; 🇨🇳 Wenzhou, Zhejiang, China