mNGS vs Culture Critically Ill Patients

• Conditions: Sepsis

• Registration Number: NCT03760315
• Lead Sponsor: Southeast University, China

Brief Summary

mNGS is popular in research and recently it has been used clinically to detect microbes in the blood or other secretion in infected patients for quicker ,broad and accurate detection of microbes. In ICU ,patients are critically ill and need quicker and accurate antibiotics use to stop the pathologic process. The purpose of this study was to determine whether the positive detection rate of pathogens in patients with sepsis by metagenomic full-targeted detection technology was higher than that in blood culture, and to determine whether the pathogens found in patients with sepsis by metagenomic full-targeted detection technology were important for clinical development. Anti-infective regimens can help.

Detailed Description

Sepsis patients in ICU were took blood culture sample and blood sample for mNGS test (IDSeqTM Ultra, Combing with Metagenomics and Pathogen/AMR/VF Probe Enrichment). Clinicians use their knowledge and experience to decide antibiotics use with the guide of Culture results or mNGS results. Validation with digital droplet PCR assays when metagenomic full-targeted assays identify pathogens not identified in conventional blood cultures The difference between the positive rate of mNGS and the positive rate of blood culture were recorded. Patient were followed at least 28 days after enrollment or an outcome indicator. Possible scenarios for detecting clinical impact were detected. Etiology, biochemical indicators, immune function, infection indicator, secondary infection, SOFA score and length of stay，outcome were recorded.

Study Timeline

• Study First Submitted: 2018-11-28
• Study First Submitted QC: 2018-11-29
• Study First Posted: 2018-11-30
• Study Start: 2022-04-01
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-02
• Last Update Posted: 2022-08-05
• Primary Completion: 2022-12-30
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

Age > 18years admit to ICU Meet the Sepsis 3.0 diagnostic criteria and suspected bloodstream infection, and the diagnosis of Sepsis ≤ 24 hours; Estimated ICU stay ≥ 24 hours; Informed consent;

Exclusion Criteria

Severe organ dysfunction, expected death within 72 hours; Receive palliative care; Refuse to participate;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
difference of positive rate between mNGS and Culture	28 day	The difference between the positive rate of mNGS and the positive rate of blood culture.

Secondary Outcome Measures

Name	Time	Method
The difference between the positive rate of metagenomic full capture technology and the Category of Clinical Impact	28 day	Positive, Negative，None and Indeterminate
Length of stay	During hospitalization	ICU and hospital length of stay
Mortality	During hospitalization	28 day，ICU and hospital mortality Documented microbiologic eradication:Absence of primary microbe from infection site Presumed microbiologic eradication:Clinical cure without available microbiologic culture data Presumed microbiologic persistence:Clinical failure in the absence of any microbiologic data Documented microbiologic persistence:Continued presence of MRSA based on microbiologic culture Superinfection: Clinical failure and isolation of a pathogen not present at baseline at the original infection site
Anti-infective treatment adjustment	28 day	each Anti-infective treatment adjustment
Change of SOFA	7 day	change of SOFA score (include each organ) at baseline, day 3 and day 7 clinical improvement :Improvement in 2 or more clinical signs and symptoms no requirement for additional antibacterial treatment Clinical failure:Persistence or progression of baseline signs and symptoms

Trial Locations

Locations (1)

Nanjing Zhong-Da Hospital; 🇨🇳 Nanjing, Jiangsu, China