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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05187871
Other study ID # SRDPAI
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date August 10, 2021
Est. completion date December 31, 2022

Study information

Verified date November 2021
Source Peking Union Medical College Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a prospective and exploratory study, which utilizes non-targeted metagenomic next-generation sequencing (mNGS) detecting drain fluid from patients who are suspected of postoperative abdominal infection. This study aims to explore the clinical value of mNGS in the rapid diagnosis of postoperative abdominal infection, to refine the pathogenic bacteria spectrum, and to establish a novel procedure for postoperative abdominal infection diagnosis.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 30
Est. completion date December 31, 2022
Est. primary completion date September 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Patients who receive abdominal operations with routinely abdominal drainage placement. 2. Abdominal infection is suspected by the clinicians, and one of the following conditions is met: 1. Temperature =38?; 2. One of the following laboratory indicators: WBC=10×10^9/L, PCT=0.5ng/ml, hsCRP=100mg/L. Exclusion Criteria: 1. Patients who are diagnosed with the abdominal infection before surgery. 2. Evidence of non-abdominal infection is clear and could explain the clinical symptoms.

Study Design


Locations

Country Name City State
China Peking Union Medical College Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The pathogenic spectrum of postoperative abdominal infection Through study completion, an average of 1 year
Secondary Consistency between mNGS and conventional culture methods Through study completion, an average of 1 year
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