NCT05149547

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 26, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 8, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

December 8, 2021

Status Verified

November 1, 2021

Enrollment Period

8 months

First QC Date

November 26, 2021

Last Update Submit

November 26, 2021

Conditions

InfectionsHematologic DiseasesFebrile Neutropenia

Outcome Measures

Primary Outcomes (1)

  • diagnosis performance

    the sensitivity and specificity of mNGS

    14 days after sapmpling

Interventions

blood culture versus mNGS detectionDIAGNOSTIC_TEST

peripheral 4ml for mNGS detection

Eligibility Criteria

Age15 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with hematologic disease during febrile neutropenia

You may qualify if:

  • hematologic disease
  • febrile neutropenia

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yuqian Sun

Beijing, China

RECRUITING

MeSH Terms

Conditions

InfectionsHematologic DiseasesFebrile Neutropenia

Condition Hierarchy (Ancestors)

Hemic and Lymphatic DiseasesNeutropeniaAgranulocytosisLeukopeniaCytopeniaLeukocyte Disorders

Study Officials

  • YUQIAN SUN, MD

    Peiking University People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuqian Sun, MD

CONTACT

861088324577sunyuqian83@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Peking University Institute of Hematology

Study Record Dates

First Submitted

November 26, 2021

First Posted

December 8, 2021

Study Start

October 15, 2021

Primary Completion

May 31, 2022

Study Completion

August 31, 2022

Last Updated

December 8, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)