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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05190861
• Other study ID #: PROGRESS
• Status: Recruiting
• Phase: N/A
• Start date: November 29, 2021
• Est. completion date: June 1, 2023

Study information

• Verified date: January 2022
• Source: Huashan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: June 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sepsis
• Septic Shock
• Toxemia

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Xiangya Hospital Central South University	Changsha	Hunan
China	The First Affiliated Hospital of Anhui Medical University	Hefei	Anhui
China	Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine	Nanjing	Jiangsu
China	Zhejiang Rui'an People's Hospital	Rui'an	Zhejiang
China	Minhang Branch of Ruijin Hospital	Shanghai	Shanghai
China	Shanghai Sixth People's Hospital	Shanghai	Shanghai
China	Xinhua Hospital Affliated to Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai
China	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang
China	Wuxi No.5 People's Hospital	Wuxi	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Huashan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 96 hours post blood collection
Primary	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.	Up to 96 hours post blood collection
Secondary	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
Secondary	Number of patients with targeted antimicrobial therapy		Up to the end of study participation, an average of 1 year
Secondary	Time to identification of a potential pathogen		At time point of identification of a potential pathogen, up to 96 hours post blood collection
Secondary	Duration of antimicrobials		Up to the end of study participation, an average of 1 year
Secondary	Change in condition severity	The sequential organ failure assessment score (SOFA score), previously known as the sepsis-related organ failure assessment score, higher scores mean worse outcome.	Up to the end of study participation, an average of 1 year
Secondary	Days in intensive care unit (ICU)		Up to the end of study participation, an average of 1 year
Secondary	Ventilation duration in ICU (hours)		Up to the end of study participation, an average of 1 year
Secondary	Days in hospital (from study inclusion)		Up to the end of study participation, an average of 1 year
Secondary	All-cause death		Up to the end of study participation, an average of 1 year
Secondary	Treatment costs		Up to the end of study participation, an average of 1 year
Secondary	Quality of life of survivors after being discharged	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.	Up to the end of study participation, an average of 1 year