Status:
COMPLETED
Efficacy, Security, Adherence, Tolerability and Cost Effectiveness of Latent TB Treatment in Patients With TB/DM2 (TBL)
Lead Sponsor:
Instituto Nacional de Salud Publica, Mexico
Collaborating Sponsors:
Instituto Nacional de Enfermedades Respiratorias
Instituto Nacional de Ciencias Medicas y Nutrición
Conditions:
Diabetes Mellitus
Tuberculin (Skin Test) Positive
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
Researchers will evaluate the efficacy, toxicity, adherence and cost effectiveness of treatment with isoniazid or rifampicin in patients with diabetes mellitus type two (DM2) and latent TB (LTB). Thi...
Detailed Description
This study is a randomized control trial, with two parallel arms, fixed assignment, fixed sample size and in two study sites. Participants will be assigned 1:1 to receive one of the two treatment regi...
Eligibility Criteria
Inclusion
- Type 2 diabetes mellitus (DM2) diagnosed based on the National Official Norm
- respiratory symptoms
- Tuberculin Skin Test (TST) \>10mm of induration
- chest X ray without pleural, lung or mediastinal lesions
- hemoglobin \< 8 gm/dl
- platelets \> 60,000 per microliter
- bilirubin \< 2.5 mg/dl
- Aspartate aminotransferase (AST) , Glutamic oxalacetic transaminases (SGOT) and alkaline phosphatase less than twice the normal value
- negative pregnancy test
- negative Human immunodeficiency virus infection test (HIV test)
- signed written informed consent.
Exclusion
- Attending selected cites
- Respiratory symptoms defined as cough with or without sputum for more than 2 weeks
- Evidence or clinical suspicion of active tuberculosis (TB)
- Current treatment with antituberculous drugs
- History of having received more than one month's treatment for latent Tuberculosis (LTB) or antituberculous drugs
- Hypersensitivity or intolerance to isoniazid or rifampicin
- Active hepatopathy
- Grade III or higher peripheral neuropathy
- Chronic alcohol ingestion
- Contacts of patients with isoniazid or rifampicin drug resistance
Key Trial Info
Start Date :
February 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2019
Estimated Enrollment :
396 Patients enrolled
Trial Details
Trial ID
NCT03278483
Start Date
February 28 2019
End Date
February 28 2019
Last Update
April 26 2019
Active Locations (1)
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1
Instituto Nacional de Ciencias Medicas y Nutrición
Mexico City, Mexico, 14000