Latent TuberculosisPhase 4NCT03498534
Evaluation of Diabetes Control and Effect on Transmission and Development of Tuberculosis
A Phase 4 study testing Isoniazid 300Mg Tab and Isoniazid 300 MG in people with Latent Tuberculosis and Diabetes Mellitus, run by Instituto Nacional de Salud Publica, Mexico.
Trial summary
Clinical test (essay) randomized to evaluate the toxicity adherence and efficiency of the chemoprophylaxis of tuberculosis (TB) in subjects with Diabetes Mellitus (DM) and latent TB. (600 subjects followed(continued) by 15 months). 3rd stage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Latent Tuberculosis, Diabetes Mellitus
- What is being tested?
- Isoniazid 300Mg Tab and Isoniazid 300 MG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2012to Dec 2013
- Phase
- Phase 4
- 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
- Positive HIV TST tuberculin
Who cannot join
- Previous TB treatment Hepatic failure AIDS
About this study
Official title: Evaluation of the Impact of Diabetes Control on Transmission and Development of Tuberculosis in the General Population
Clinical test (essay) randomized to evaluate the toxicity adherence and efficiency of the chemoprophylaxis of tuberculosis (TB) in subjects with Diabetes Mellitus (DM) and latent TB. (600 subjects followed(continued) by 15 months). 3rd stage. Patients with DM and TB will be included to determine if the strict control of the dm achieved in clinics of the first level of attention improves clinical manifestations of tb, the result of treatment, the frequency of relapses, the mortality and the transmission to contacts.
Elispot will be used to measure TB development and the time for the bacteriological negativization and biochemical parameters as well as tuberculin skin test (TST), quantiferon, in contacts. (160 patients 600 contacts followed(continued) for 12 months). additional there will be evaluated the socioeconomic impact of both diseases and his(her) control. 1er year: transverse study and recruitment years 2 and 3 participants' follow-ups in clinical tests(essays).
- Conditions
- Latent Tuberculosis, Diabetes Mellitus
- Being tested
- Isoniazid 300Mg Tab, Isoniazid 300 MG
- Keywords
- Treatment, Latent infection, Tuberculosis, Interferon gamma
- Medical subject headings
- Latent Tuberculosis, Diabetes Mellitus, Latent Infection, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isoniazid 300Mg TabDrug
Also called Isoniazid 300 mgs.
-TST tests will receive isoniazid 300Mg Tab for 6 months
Isoniazid 300 MGDrug
Also called Isoniazid
+ TST test will receive isoniazid 300MG Tab for 6 months
Isoniazid 300 MGDrug
Also called Isoniazid 300 mg per day
HIV positive patient will receive isoniazid 300MGTab for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Patients with a -TST | Active comparator | In all patients with a negative TST test, Isoniazid 300 mg per day will be administered for 6 months Receives: Drug: Isoniazid 300Mg Tab |
| Patients with a +TST | Active comparator | In patients with a +TST test researchers will test for HIV, hepatic function and we will take a chest x-ray. Isoniazid 300 mg per day will be administered for 6 months Receives: Drug: Isoniazid 300 MG |
| HIV positive patients | Active comparator | The researchers will test hepatic function and take a chest x-ray. Isoniazid 300 mg per day will be administered for 6 months Receives: Drug: Isoniazid 300 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of active TB
Researchers will test patients at day 0 and day 180 of treatment to detect the development of active TB
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2018
- Study startSep 2012
- Primary completionDec 2012 (estimated)
- Study completionDec 2013 (estimated)
Why it stopped: Due to administrative procedures
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Latent 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 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Salud Publica, Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ma. de Lourdes Garcia Garcia, Instituto Nacional de Salud Publica, Mexico
- Investigators
- Garcia-Garcia Lourdes, Doctor, Principal investigator, National Institute of public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03498534
- Sponsor's protocol ID
- CI-543
- Status last verified
- Apr 2018
- First submitted
- 28 Mar 2012
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Diabetes Control on Transmission and Development of Tuberculosis in the General Population
- ClinicalTrials.gov ID
- NCT03498534
- Acronym / sponsor ID
- CI-543
- Conditions
- Latent Tuberculosis, Diabetes Mellitus
- Keywords
- Treatment, Latent infection, Tuberculosis, Interferon gamma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to administrative procedures
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Instituto Nacional de Salud Publica, MexicoUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 13 Apr 2018 (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.
Clinical test (essay) randomized to evaluate the toxicity adherence and efficiency of the chemoprophylaxis of tuberculosis (TB) in subjects with Diabetes Mellitus (DM) and latent TB. (600 subjects followed(continued) by 15 months). 3rd stage. Patients with DM and TB will be included to determine if the strict control of the dm achieved in clinics of the first level of attention improves clinical manifestations of tb, the result of treatment, the frequency of relapses, the mortality and the transmission to contacts.
Elispot will be used to measure TB development and the time for the bacteriological negativization and biochemical parameters as well as tuberculin skin test (TST), quantiferon, in contacts. (160 patients 600 contacts followed(continued) for 12 months). additional there will be evaluated the socioeconomic impact of both diseases and his(her) control. 1er year: transverse study and recruitment years 2 and 3 participants' follow-ups in clinical tests(essays).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with a -TST | Active comparator | Drug: Isoniazid 300Mg TabIn all patients with a negative TST test, Isoniazid 300 mg per day will be administered for 6 months |
| Patients with a +TST | Active comparator | Drug: Isoniazid 300 MGIn patients with a +TST test researchers will test for HIV, hepatic function and we will take a chest x-ray. Isoniazid 300 mg per day will be administered for 6 months |
| HIV positive patients | Active comparator | Drug: Isoniazid 300 MGThe researchers will test hepatic function and take a chest x-ray. Isoniazid 300 mg per day will be administered for 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Positive HIV TST tuberculin
Key exclusion criteria (1 listed)
- Previous TB treatment Hepatic failure AIDS
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 |
|---|---|---|
| Isoniazid 300Mg TabAlso: Isoniazid 300 mgs.-TST tests will receive isoniazid 300Mg Tab for 6 months | Drug | Patients with a -TST |
| Isoniazid 300 MGAlso: Isoniazid+ TST test will receive isoniazid 300MG Tab for 6 months | Drug | Patients with a +TST |
| Isoniazid 300 MGAlso: Isoniazid 300 mg per dayHIV positive patient will receive isoniazid 300MGTab for 6 months | Drug | HIV positive patients |
Primary outcome
Development of active TB
Time frame: 6 months
Researchers will test patients at day 0 and day 180 of treatment to detect the development of active TB
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
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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.
Garcia-Garcia Lourdes, Doctor principal investigator
National Institute of public Health
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Isoniazid 300Mg Tab and Isoniazid 300 MG in people with Latent Tuberculosis and Diabetes Mellitus, run by Instituto Nacional de Salud Publica, Mexico.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Development of active TB (time frame: 6 months). 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 17 Apr 2018.