NCT06485895

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
21mo left

Started Jul 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress52%
Jul 2024Feb 2028

First Submitted

Initial submission to the registry

June 26, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 3, 2024

Completed
27 days until next milestone

Study Start

First participant enrolled

July 30, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

August 1, 2024

Status Verified

July 1, 2024

Enrollment Period

3 years

First QC Date

June 26, 2024

Last Update Submit

July 31, 2024

Conditions

TUBERCULOSIS

Outcome Measures

Primary Outcomes (2)

  • sensitivity of TB-IGRA 2nd generation test

    24 MONTHS

  • specificity of TB-IGRA 2nd generation test

    24 MONTHS

Study Arms (1)

TUBERCULOSIS (LATENTE OR ACTIVE) ARM

EXPERIMENTAL
Diagnostic Test: test IGRADiagnostic Test: TEST QUATIFERON TB Gold Plus

Interventions

test IGRADIAGNOSTIC_TEST

BLOOD SAMPLES

TUBERCULOSIS (LATENTE OR ACTIVE) ARM
TEST QUATIFERON TB Gold PlusDIAGNOSTIC_TEST

BLOOD SAMPLES

TUBERCULOSIS (LATENTE OR ACTIVE) ARM

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, France

RECRUITING

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • François CREMIEUX

    ASSISTANCE PUBLIQUE HOPITAUX D EMARSEILLE

    STUDY DIRECTOR

Central Study Contacts

PR PIERRE EDOUARD FOURNIER PU-PH

CONTACT

33+ 04 13 73 24 31pierre-edouard.fournier@ap-hm.fr

ALEXANDRA GIULIANI PROJECT MANAGER

CONTACT

alexandra.giuliani@ap-hm.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2024

First Posted

July 3, 2024

Study Start

July 30, 2024

Primary Completion (Estimated)

July 30, 2027

Study Completion (Estimated)

February 1, 2028

Last Updated

August 1, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)