mNGS vs Culture Critically Ill Patients
Department of Critical Care Medicine, Nanjing Zhong-Da Hospital, Southeast University School of Medicine,China;
1 other identifier
observational
210
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 28, 2018
CompletedFirst Posted
Study publicly available on registry
November 30, 2018
CompletedStudy Start
First participant enrolled
April 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2022
CompletedAugust 5, 2022
August 1, 2022
9 months
November 28, 2018
August 2, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
difference of positive rate between mNGS and Culture
The difference between the positive rate of mNGS and the positive rate of blood culture.
28 day
Secondary Outcomes (5)
The difference between the positive rate of metagenomic full capture technology and the Category of Clinical Impact
28 day
Change of SOFA
7 day
Mortality
During hospitalization
Length of stay
During hospitalization
Anti-infective treatment adjustment
28 day
Other Outcomes (2)
pathogen
28 day
secondary infection
28 day
Study Arms (1)
Sepsis
All enrolled patients
Interventions
take blood samples for mNGS and Culture at the same time in sepsis patients. No intervention on the treatment of the patients.
Eligibility Criteria
Patient with sepsis and suspected bloodstream infection
You may qualify if:
- 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;
You may not qualify if:
- Severe organ dysfunction, expected death within 72 hours; Receive palliative care; Refuse to participate;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nanjing Zhong-Da Hospital
Nanjing, Jiangsu, 210009, China
Related Publications (1)
Sun Q, Teng R, Shi Q, Liu Y, Cai X, Yang B, Cao Q, Shu C, Mei X, Zeng W, Hu B, Zhang J, Qiu H, Liu L. Clinical implement of Probe-Capture Metagenomics in sepsis patients: A multicentre and prospective study. Clin Transl Med. 2025 Apr;15(4):e70297. doi: 10.1002/ctm2.70297.
PMID: 40181528DERIVED
Biospecimen
DNA extracted from blood
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Haibo Qiu, MD
Southeast University, China
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
November 28, 2018
First Posted
November 30, 2018
Study Start
April 1, 2022
Primary Completion
December 30, 2022
Study Completion
December 30, 2022
Last Updated
August 5, 2022
Record last verified: 2022-08