| Trial ID: | L6470 |
| Source ID: | NCT03278483
|
| Associated Drug: |
Isoniazid 300 Mg Oral Tablet
|
| Title: |
Efficacy, Security, Adherence, Tolerability and Cost Effectiveness of Latent TB Treatment in Patients With TB/DM2 (TBL)
|
| Acronym: |
TBL
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus|Tuberculin (Skin Test) Positive
|
| Interventions: |
DRUG: Isoniazid 300 mg Oral Tablet|DRUG: Rifampin 600 mg Oral Tablet
|
| Outcome Measures: |
Primary: Efficacy of treatment with rifampicin compared to efficacy of treatment with isoniazid, Researchers will measure with ELISA in vitro production of interferon gamma of peripheric mononuclear cels as a response to stimuli by RV0849 and RV1737 antigens. The cut of value is of \>100pg/ml., Up to 18 months|Toxicity (neuropathy), Neurological alterations will be assessed using the Michigan questionnaire and in a subsample they will evaluate neuropathy using electroneurography., Up to 6 months|Adherence, Counting the number of administered pills, adequate adherence is more than 80% of administered pills., Up to 6 months|Toxicity (liver function), Liver function tests, Up to 6 months |
|
| Sponsor/Collaborators: |
Sponsor: Instituto Nacional de Salud Publica, Mexico | Collaborators: Instituto Nacional de Enfermedades Respiratorias|Instituto Nacional de Ciencias Medicas y Nutrición
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
396
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2019-02-28
|
| Completion Date: |
2019-02-28
|
| Results First Posted: |
|
| Last Update Posted: |
2019-04-26
|
| Locations: |
Instituto Nacional de Ciencias Medicas y Nutrición, Mexico City, 14000, Mexico
|
| URL: |
https://clinicaltrials.gov/show/NCT03278483
|
