TuberculosisNCT02861768
Improving the Diagnostic of Tuberculosis
A study testing Pharyngeal swab in people with Tuberculosis, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
The presence of M. tuberculosis in non-invasive throat swabs of patients withdrawn for suspected tuberculosis. Hypothesis 10% of patients infected by M. tuberculosis are carrier of M. tuberculosis pharyngeal. Secondary 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculosis
- What is being tested?
- Pharyngeal swab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 991 participants
- Where
- 1 siteFrance
- Study dates
- 22 Mar 2013to 8 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patient taken for microbiological examinations "kit mycobacterium"
- Patient Major (> 18 years).
- Patient who freely signed the informed written consent.
- Patient affiliated to a system of social security. Exclusion criteria
- Patient minor (<18 years).
- Patient pregnant or nursing.
Show all 9Show fewer
- Major Patient under guardianship.
- Private Patient liberty or under court order.
- Patient refusing to sign the informed consent form.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The presence of M. tuberculosis in non-invasive throat swabs of patients withdrawn for suspected tuberculosis.
Hypothesis 10% of patients infected by M. tuberculosis are carrier of M. tuberculosis pharyngeal.
Secondary
- Measure the time to diagnosis of pulmonary TB by comparing the sample versus noninvasive pharyngeal samples taken routinely.
- Evaluation of the direct cost of the diagnosis of M. tuberculosis by comparing the sample versus noninvasive pharyngeal samples taken routinely.
- Beijing genotype prevalence among patients with pulmonary tuberculosis.
- Conditions
- Tuberculosis
- Being tested
- Pharyngeal swab
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharyngeal swabBiological
| Study group | Role | What they receive |
|---|---|---|
| diagnosis of M.tuberculosis infection | Experimental | Not described Receives: Biological: Pharyngeal swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with microbiological diagnosis of M. tuberculosis infection
Measured: 3 years
Secondary outcomes (3)
pulmonary tuberculosis diagnostic time.
Measured: 3years
Prevalence of diagnosed patients Beijing
Measured: 3 years
Direct cost of microbiological diagnosis of extra Beijing genotype
(compared to the cost of the kit TB), reported the percentage of patients diagnosed Beijing.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2016 (estimated)
- Study start22 Mar 2013
- Primary completion8 Feb 2019
- Study completion8 Feb 2019
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.
- 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
- 991 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- catherine GEINDRE, Study director, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02861768
- Sponsor's protocol ID
- 2012-49
- Other IDs
- 2012-A01598-35
- Status last verified
- Aug 2016
- First submitted
- 5 Aug 2016
- Last updated
- 21 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Diagnostic of Tuberculosis
- ClinicalTrials.gov ID
- NCT02861768
- Acronym / sponsor ID
- 2012-49
- Conditions
- Tuberculosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 991 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 22 Mar 2013
- Primary completion
- 8 Feb 2019 (actual)
- Study completion
- 8 Feb 2019 (actual)
- First posted
- 10 Aug 2016 (estimated)
- 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.
The presence of M. tuberculosis in non-invasive throat swabs of patients withdrawn for suspected tuberculosis.
Hypothesis 10% of patients infected by M. tuberculosis are carrier of M. tuberculosis pharyngeal.
Secondary
- Measure the time to diagnosis of pulmonary TB by comparing the sample versus noninvasive pharyngeal samples taken routinely.
- Evaluation of the direct cost of the diagnosis of M. tuberculosis by comparing the sample versus noninvasive pharyngeal samples taken routinely.
- Beijing genotype prevalence among patients with pulmonary tuberculosis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| diagnosis of M.tuberculosis infection | Experimental | Biological: Pharyngeal swab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient taken for microbiological examinations "kit mycobacterium"
- Patient Major (> 18 years).
- Patient who freely signed the informed written consent.
- Patient affiliated to a system of social security. Exclusion criteria
- Patient minor (<18 years).
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Pharyngeal swab | Biological | diagnosis of M.tuberculosis infection |
Primary outcome
Percentage of patients with microbiological diagnosis of M. tuberculosis infection
Time frame: 3 years
3 secondary outcomes
pulmonary tuberculosis diagnostic time.
Time frame: 3years
Prevalence of diagnosed patients Beijing
Time frame: 3 years
Direct cost of microbiological diagnosis of extra Beijing genotype
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
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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. This study is not recruiting at the moment.
catherine GEINDRE study director
Assistance Publique Hopitaux De Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharyngeal swab 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 9 inclusion and 0 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: finished, as of the sponsor's last update on 21 Apr 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with microbiological diagnosis of M. tuberculosis infection (time frame: 3 years). 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 21 Apr 2023.