mNGS Versus Blood Culture in FN

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05149547

Enrollment

300

Registered

2021-12-08

Start date

2021-10-15

Completion date

2022-08-31

Last updated

2021-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Febrile Neutropenia, Hematologic Diseases, Infections

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.

Interventions

DIAGNOSTIC_TESTblood culture versus mNGS detection

peripheral 4ml for mNGS detection

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

15 Years to No maximum

Inclusion criteria

* hematologic disease * febrile neutropenia

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
diagnosis performance	14 days after sapmpling	the sensitivity and specificity of mNGS

Countries

China

Contacts

Primary ContactYuqian Sun, MD

sunyuqian83@hotmail.com861088324577

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026