Clinical Evaluation of an IGRA Test for the Diagnosis of... | NCT06485895

Studies
Clinical Evaluation of an IGRA Test for the Diagnosis of Active and Latent Tuberculosis

NCT06485895

Sponsor

Assistance Publique Hopitaux De Marseille

Status

Recruiting

Last Update Posted

Aug 1, 2024Actual

Enrollment

500Estimated

Phase

Not Applicable

Conditions

TUBERCULOSIS

Interventions

test IGRA
TEST QUATIFERON TB Gold Plus

Countries

France

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

ID	Type	Description	Link
2024-A00322-45	Other Identifier	N°IDRCB

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 30, 2024Actual

Primary Completion Date

Jul 30, 2027Estimated

Completion Date

Feb 1, 2028Estimated

First Submitted Date

Jun 26, 2024

First Submission Date that Met QC Criteria

Jul 2, 2024

First Posted Date

Jul 3, 2024Actual

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

Jul 31, 2024

Last Update Posted Date

Aug 1, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Methodology This is a single-center study carried out as part of routine patient care.

The aim of the study is to determine the performance of the 2nd generation TB-IGRA test in the diagnosis of tuberculosis.

Detailed Description

It is planned to include 500 patients. An enrolment of 455 subjects will enable us to demonstrate sensitivity-specificity levels of 92% for a 95% confidence interval and a 0.05 degree of precision. To take account of non-analyzable samples or tests, the investigator will include 500 subjects

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TUBERCULOSIS (LATENTE OR ACTIVE) ARM	Experimental		Diagnostic Test: test IGRA Diagnostic Test: TEST QUATIFERON TB Gold Plus

Interventions

Name	Type	Description	Arm Group Labels	Other Names
test IGRA	Diagnostic Test	BLOOD SAMPLES	TUBERCULOSIS (LATENTE OR ACTIVE) ARM

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
sensitivity of TB-IGRA 2nd generation test		24 MONTHS
specificity of TB-IGRA 2nd generation test		24 MONTHS

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Individual at least 18 years of age
Patient presenting for treatment of tuberculosis disease
Having undergone or benefiting from screening for tuberculosis using a medically prescribed reference IGRA test.
Informed patient who has not expressed opposition to participating in the study.

French-speaking patient with unambiguous understanding of oral and written instructions.

Exclusion Criteria:

Persons in a period of exclusion from another study

Pregnant, parturient or breast-feeding women;
Person deprived of liberty by judicial or administrative decision

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
PR PIERRE EDOUARD FOURNIER PU-PH	Contact	33+ 04 13 73 24 31		pierre-edouard.fournier@ap-hm.fr
ALEXANDRA GIULIANI PROJECT MANAGER	Contact			alexandra.giuliani@ap-hm.fr

Overall Officials

Name	Affiliation	Role
François CREMIEUX	ASSISTANCE PUBLIQUE HOPITAUX D EMARSEILLE	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assistance Publique Hopitaux de Marseille	Recruiting	Marseille			France

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
D014376	Tuberculosis

Ancestor Terms

ID	Term
D009164	Mycobacterium Infections
D000193	Actinomycetales Infections
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections

Browse Leaves

Not provided

Browse Branches

Not provided