Detection of Pathogen and Antibiotic Resistance Genes by Targeted Next-Generation Sequencing in ICU Patients.
1 other identifier
observational
20
0 countries
N/A
Brief Summary
It is difficult to determine the pathogens in the early stage of infection in critically ill patients, and empirical use of broad-spectrum antibiotics for a long time is often necessary, leading to antibiotics drug resistance. Targeted next generation sequencing (tNGS) can provide faster results for pathogen and related antibiotic resistant diagnosis. But it lacks sufficient clinical evidence. Evidence regarding the clinical diagnostic accuracy and drug resistance is needed to comprehensively evaluate targeted next generation sequencing (tNGS) for diagnosis of patients in ICU who and will be critical to inform national policy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Dec 2023
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 19, 2023
CompletedFirst Posted
Study publicly available on registry
December 5, 2023
CompletedStudy Start
First participant enrolled
December 20, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 10, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 10, 2024
CompletedDecember 5, 2023
November 1, 2023
8 months
October 19, 2023
November 27, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Sensitivity
The probability of being positive in clinical composite diagnosis, the probability that etiological culture, mNGS, and tNGS tests are also positive, which is also known as the true positive rate.
1 year
Specificity
It refers to the probability that cultures, mNGS, and tNGS tests are also negative in the presence of non-infection confirmed by the gold standard.
1 year
Secondary Outcomes (6)
False-positive rate
1 year
False-negative rate
1 year
Positive predictive value
1 year
Negative predictive value
1 year
Kappa values
1 year
- +1 more secondary outcomes
Study Arms (2)
Non-Infection group
Participants received traditional etiological culture of suspected site of infection.
Infection group
Participants received traditional etiological culture, metagenomic next-generation sequencing of infectious sites.
Interventions
To provide rapid etiological diagnosis of patients by means of targeted next-generation sequencing.
Eligibility Criteria
Patients in ICU truly have infected disease and non-infected disease diagnosed by two ICU physicians determining whether the patient have an infectious etiology and identifying the pathogen through existing clinical guidelines, clinical features, laboratory tests, microbiological tests, chest imaging, and treatment response.
You may qualify if:
- The presence of an infection or clearly excluded the presence of infection.
- Etiological culture and/or metagenomic next-generation sequencing detection of specimens sent for testing.
You may not qualify if:
- Suspected infection.
- Participation in other clinical trials in the past 2 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (6)
Chiu CY, Miller SA. Clinical metagenomics. Nat Rev Genet. 2019 Jun;20(6):341-355. doi: 10.1038/s41576-019-0113-7.
PMID: 30918369BACKGROUNDDiao Z, Han D, Zhang R, Li J. Metagenomics next-generation sequencing tests take the stage in the diagnosis of lower respiratory tract infections. J Adv Res. 2021 Sep 29;38:201-212. doi: 10.1016/j.jare.2021.09.012. eCollection 2022 May.
PMID: 35572406BACKGROUNDMiao Q, Ma Y, Wang Q, Pan J, Zhang Y, Jin W, Yao Y, Su Y, Huang Y, Wang M, Li B, Li H, Zhou C, Li C, Ye M, Xu X, Li Y, Hu B. Microbiological Diagnostic Performance of Metagenomic Next-generation Sequencing When Applied to Clinical Practice. Clin Infect Dis. 2018 Nov 13;67(suppl_2):S231-S240. doi: 10.1093/cid/ciy693.
PMID: 30423048BACKGROUNDPei XM, Yeung MHY, Wong ANN, Tsang HF, Yu ACS, Yim AKY, Wong SCC. Targeted Sequencing Approach and Its Clinical Applications for the Molecular Diagnosis of Human Diseases. Cells. 2023 Feb 2;12(3):493. doi: 10.3390/cells12030493.
PMID: 36766834BACKGROUNDLi S, Tong J, Liu Y, Shen W, Hu P. Targeted next generation sequencing is comparable with metagenomic next generation sequencing in adults with pneumonia for pathogenic microorganism detection. J Infect. 2022 Nov;85(5):e127-e129. doi: 10.1016/j.jinf.2022.08.022. Epub 2022 Aug 26. No abstract available.
PMID: 36031154BACKGROUNDGaston DC, Miller HB, Fissel JA, Jacobs E, Gough E, Wu J, Klein EY, Carroll KC, Simner PJ. Evaluation of Metagenomic and Targeted Next-Generation Sequencing Workflows for Detection of Respiratory Pathogens from Bronchoalveolar Lavage Fluid Specimens. J Clin Microbiol. 2022 Jul 20;60(7):e0052622. doi: 10.1128/jcm.00526-22. Epub 2022 Jun 13.
PMID: 35695488BACKGROUND
Biospecimen
Blood samples and qualified lower respiratory tract specimens (LRS), including bronchoalveolar lavage fluid (BALF), pleural/peritoneal effusion, lymph node tissue and other suspected infected tissues are obtained from patients after including and preferred to be collected before the antimicrobial therapy began.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Zhijie He
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2023
First Posted
December 5, 2023
Study Start
December 20, 2023
Primary Completion
August 10, 2024
Study Completion
August 10, 2024
Last Updated
December 5, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share