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NCT05149547 Clinical Trial

mNGS Versus Blood Culture in FN

Infections Clinical Trial

Official title:
The Comparison of mNGS Versus Blood Culture for Early Diagnosis of Blood Stream Infection During the Febrile Neutropenia in Patients With Hematological Disease

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05149547
Other study ID # mNGS for FN(2021PHB362-001)
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 15, 2021
Est. completion date August 31, 2022

Study information
Verified date November 2021
Source Peking University People's Hospital
Contact Yuqian Sun, MD
Phone 861088324577
Email sunyuqian83@hotmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date August 31, 2022
Est. primary completion date May 31, 2022
Accepts healthy volunteers
Gender All
Age group 15 Years and older
Eligibility Inclusion Criteria: - hematologic disease - febrile neutropenia Exclusion Criteria: - refuse to consent - age<=14 - not caused by infection

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• blood culture versus mNGS detection
peripheral 4ml for mNGS detection

Locations
Country Name City State
China Yuqian Sun Beijing

Sponsors (4)
Lead Sponsor Collaborator
Peking University People's Hospital Hebei Yanda Ludaopei Hospital, Peking University First Hospital, Peking University International Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary diagnosis performance the sensitivity and specificity of mNGS 14 days after sapmpling
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