mNGS Versus Blood Culture in FN

• Conditions: Infections; Hematologic Diseases; Febrile Neutropenia

• Registration Number: NCT05149547
• Lead Sponsor: Peking University People's Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-15
• Status Verified: 2021-11
• Study First Submitted: 2021-11-26
• Study First Submitted QC: 2021-11-26
• Last Update Submitted: 2021-11-26
• Study First Posted: 2021-12-08
• Last Update Posted: 2021-12-08
• Primary Completion: 2022-05-31
• Study Completion: 2022-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• hematologic disease
• febrile neutropenia

Exclusion Criteria

• refuse to consent
• age<=14
• not caused by infection

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
diagnosis performance	14 days after sapmpling	the sensitivity and specificity of mNGS

Trial Locations

Locations (1)

Yuqian Sun; 🇨🇳 Beijing, China