TUBERCULOSISTUBIGRANCT06485895
Clinical Evaluation of an IGRA Test for the Diagnosis of Active and Latent Tuberculosis
A study testing test IGRA and TEST QUATIFERON TB Gold Plus in people with TUBERCULOSIS, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- TUBERCULOSIS
- What is being tested?
- test IGRA and TEST QUATIFERON TB Gold Plus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jul 2024to 1 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Persons in a period of exclusion from another study
- Pregnant, parturient or breast-feeding women;
- Person deprived of liberty by judicial or administrative decision
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
ALEXANDRA GIULIANI PROJECT MANAGER contact
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hopitaux de Marseille
Marseille
ALEXANDRA GIULIANI, alexandra.giuliani@ap-hm.fr
PIERRE-EDOUARD FOURNIER
About this study
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.
Read the 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
- Conditions
- TUBERCULOSIS
- Being tested
- test IGRA, TEST QUATIFERON TB Gold Plus
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
test IGRADiagnostic test
BLOOD SAMPLES
TEST QUATIFERON TB Gold PlusDiagnostic test
BLOOD SAMPLES
| Study group | Role | What they receive |
|---|---|---|
| TUBERCULOSIS (LATENTE OR ACTIVE) ARM | Experimental | Not described Receives: Diagnostic Test: test IGRA; Diagnostic Test: TEST QUATIFERON TB Gold Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity of TB-IGRA 2nd generation test
Measured: 24 MONTHS
specificity of TB-IGRA 2nd generation test
Measured: 24 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start30 Jul 2024
- Primary completion30 Jul 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TUBERCULOSISStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François CREMIEUX, Study director, ASSISTANCE PUBLIQUE HOPITAUX D EMARSEILLE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06485895
- Sponsor's protocol ID
- RCAPHM24_0100
- Other IDs
- 2024-A00322-45
- Acronym
- TUBIGRA
- Status last verified
- Jul 2024
- First submitted
- 26 Jun 2024
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of an IGRA Test for the Diagnosis of Active and Latent Tuberculosis
- ClinicalTrials.gov ID
- NCT06485895
- Acronym / sponsor ID
- TUBIGRA / RCAPHM24_0100
- Conditions
- TUBERCULOSIS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 30 Jul 2024 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TUBERCULOSIS (LATENTE OR ACTIVE) ARM | Experimental | Diagnostic Test: test IGRA, Diagnostic Test: TEST QUATIFERON TB Gold Plus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Persons in a period of exclusion from another study
- Pregnant, parturient or breast-feeding women;
- Person deprived of liberty by judicial or administrative decision
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| test IGRABLOOD SAMPLES | Diagnostic test | TUBERCULOSIS (LATENTE OR ACTIVE) ARM |
| TEST QUATIFERON TB Gold PlusBLOOD SAMPLES | Diagnostic test | TUBERCULOSIS (LATENTE OR ACTIVE) ARM |
Primary outcome
sensitivity of TB-IGRA 2nd generation test
Time frame: 24 MONTHS
specificity of TB-IGRA 2nd generation test
Time frame: 24 MONTHS
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ALEXANDRA GIULIANI PROJECT MANAGER contact
François CREMIEUX study director
ASSISTANCE PUBLIQUE HOPITAUX D EMARSEILLE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing test IGRA and TEST QUATIFERON TB Gold Plus in people with TUBERCULOSIS, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact PR PIERRE EDOUARD FOURNIER PU-PH (33+ 04 13 73 24 31, pierre-edouard.fournier@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensitivity of TB-IGRA 2nd generation test (time frame: 24 MONTHS). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2024.