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Detection of Pathogen and Antibiotic Resistance Genes by Targeted Next-Generation Sequencing in ICU Patients.

NCT ID: NCT06157372

Last Updated: 2023-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-20

Study Completion Date

2024-08-10

Brief Summary

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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.

Detailed Description

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Infectious diseases are one of the highest mortality and morbidity diseases in humans. Due to the difficulty in identifying the pathogen in the early stage of infection, patients with severe infections often need to empirically use broad-spectrum antimicrobials for a long time. The traditional gold standard of etiological detection - etiological culture, even in sepsis patients, only about 60% of the results are positive. Therefore, the accurate identification and rapid classification of pathogenic microorganisms is very important for the patient's precise diagnosis and timely treatment.

Metagenomic next generation sequencing (mNGS), which has emerged in recent years, have been shown to provide early diagnosis and targeted medication guidance for bloodstream infections and respiratory infections, but it is expensive and not able to provide related drug resistant genes. Therefore, targeted next generation sequencing (tNGS) has been derived, which is characterized by rapid sequencing and genetic testing for drug resistance.

The purpose of this study is to evaluate the efficacy of etiological diagnosis and provide patients with more accurate treatment.

Conditions

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Infections Critical Illness Diagnosis

Keywords

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Targeted Next-generation sequencing ICU infections Next-generation sequencing

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Non-Infection group

Participants received traditional etiological culture of suspected site of infection.

targeted next-generation sequencing (tNGS)

Intervention Type DIAGNOSTIC_TEST

To provide rapid etiological diagnosis of patients by means of targeted next-generation sequencing.

Infection group

Participants received traditional etiological culture, metagenomic next-generation sequencing of infectious sites.

targeted next-generation sequencing (tNGS)

Intervention Type DIAGNOSTIC_TEST

To provide rapid etiological diagnosis of patients by means of targeted next-generation sequencing.

Interventions

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targeted next-generation sequencing (tNGS)

To provide rapid etiological diagnosis of patients by means of targeted next-generation sequencing.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Suspected infection.
* Participation in other clinical trials in the past 2 months.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zhijie He

Role: STUDY_DIRECTOR

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Central Contacts

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Ting Li

Role: CONTACT

Phone: 011-86-15608657562

Email: [email protected]

Fangyi Li

Role: CONTACT

Phone: 011-86-15603056533

Email: [email protected]

References

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Chiu CY, Miller SA. Clinical metagenomics. Nat Rev Genet. 2019 Jun;20(6):341-355. doi: 10.1038/s41576-019-0113-7.

Reference Type BACKGROUND
PMID: 30918369 (View on PubMed)

Diao 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.

Reference Type BACKGROUND
PMID: 35572406 (View on PubMed)

Miao 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.

Reference Type BACKGROUND
PMID: 30423048 (View on PubMed)

Pei 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.

Reference Type BACKGROUND
PMID: 36766834 (View on PubMed)

Li 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.

Reference Type BACKGROUND
PMID: 36031154 (View on PubMed)

Gaston 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.

Reference Type BACKGROUND
PMID: 35695488 (View on PubMed)

Other Identifiers

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SYSKY-2023-667-03

Identifier Type: -

Identifier Source: org_study_id