mNGS Versus Blood Culture in FN

NCT ID: NCT05149547

Last Updated: 2021-12-08

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

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-15

Study Completion Date

2022-08-31

Brief Summary

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Blood stream infection (BSI) during febrile neutropenia (FN) is a lethal complication, while confirmed diagnosis via blood culture is usually with low sensitivity and time delay. The new technique of metagenome next generation sequencing (mNGS) has the potential of early and more accurate detection of pathogens. However, this technique has not been well validated for BSI diagnosis in patients with hematological disease. Therefore, we designed a prospective multicenter study to compare the diagnosis performance in BSI.

Detailed Description

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Conditions

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Infections Hematologic Diseases Febrile Neutropenia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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blood culture versus mNGS detection

peripheral 4ml for mNGS detection

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* hematologic disease
* febrile neutropenia

Exclusion Criteria

* refuse to consent
* age\<=14
* not caused by infection
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University First Hospital

OTHER

Sponsor Role collaborator

Peking University International Hospital

OTHER

Sponsor Role collaborator

Hebei Yanda Ludaopei Hospital

OTHER

Sponsor Role collaborator

Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xiao-Jun Huang

Head of Peking University Institute of Hematology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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YUQIAN SUN, MD

Role: PRINCIPAL_INVESTIGATOR

Peiking University People's Hospital

Locations

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Yuqian Sun

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yuqian Sun, MD

Role: CONTACT

Phone: 861088324577

Email: [email protected]

Facility Contacts

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YUQIAN SUN

Role: primary

Other Identifiers

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mNGS for FN(2021PHB362-001)

Identifier Type: -

Identifier Source: org_study_id