mNGS Versus Blood Culture in FN | NCT05149547

Studies
mNGS Versus Blood Culture in FN

NCT05149547

Sponsor

Peking University People's Hospital

Status

Unknown status

Last Update Posted

Dec 8, 2021Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Infections
Hematologic Diseases
Febrile Neutropenia

Interventions

blood culture versus mNGS detection

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 15, 2021Actual

Primary Completion Date

May 31, 2022Estimated

Completion Date

Aug 31, 2022Estimated

First Submitted Date

Nov 26, 2021

First Submission Date that Met QC Criteria

Nov 26, 2021

First Posted Date

Dec 8, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 26, 2021

Last Update Posted Date

Dec 8, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Xiao-Jun Huang, Head of Peking University Institute of Hematology, Peking University People's HospitalPrincipal Investigator

Lead Sponsor

Peking University People's HospitalOTHER

Collaborators

Name	Class
Peking University First Hospital	OTHER
Peking University International Hospital	OTHER
Hebei Yanda Ludaopei Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
blood culture versus mNGS detection	Diagnostic Test	peripheral 4ml for mNGS detection

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

hematologic disease
febrile neutropenia

Exclusion Criteria:

refuse to consent
age<=14
not caused by infection

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

patients with hematologic disease during febrile neutropenia

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yuqian Sun, MD	Contact	861088324577		sunyuqian83@hotmail.com

Overall Officials

Name	Affiliation	Role
YUQIAN SUN, MD	Peiking University People's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yuqian Sun	Recruiting	Beijing			China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007239	Infections
D006402	Hematologic Diseases
D064147	Febrile Neutropenia

Ancestor Terms

ID	Term
D006425	Hemic and Lymphatic Diseases
D009503	Neutropenia
D000380	Agranulocytosis
D007970	Leukopenia

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Browse Branches

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