Efficacy, Security, Adherence, Tolerability and Cost Effectiveness of Latent TB Treatment in Patients With TB/DM2 (TBL)

• Status: Completed
• Trial end date: 2019-02-28
• Target enrollment: 0
• Participant gender: All

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).

This is a collaborative study with participation from three national institutes (Instituto Nacional de Salud Pública (INSP), Instituto Nacional de Enfermedades Respiratorias (INER) and the Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubiran (INCMNSZ)).

The study will take place in the VII sanitary jurisdiction of Orizaba and the INCMNSZ that has the necessary infrastructure and human resources. Researchers will evaluate 3000 patients with diabetes using a standardized questionnaire and a tuberculin skin test (TST) test. Eligible patients will be invited to participate and from those that agree to participate and sign a written informed consent we will obtain clinical, epidemiological, nutritional and metabolic information. Patients with altered liver function tests will be excluded.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto Nacional de Salud Publica, Mexico
• Collaborators: Instituto Nacional de Ciencias Medicas y Nutrición; Instituto Nacional de Enfermedades Respiratorias
• Treatments: Isoniazid; Rifampin

Criteria

Inclusion Criteria:

1. Type 2 diabetes mellitus (DM2) diagnosed based on the National Official Norm

2. respiratory symptoms

3. Tuberculin Skin Test (TST) >10mm of induration

4. chest X ray without pleural, lung or mediastinal lesions

5. hemoglobin < 8 gm/dl

6. platelets > 60,000 per microliter

7. bilirubin < 2.5 mg/dl

8. Aspartate aminotransferase (AST) , Glutamic oxalacetic transaminases (SGOT) and alkaline phosphatase less than twice the normal value

9. negative pregnancy test

10. negative Human immunodeficiency virus infection test (HIV test)

11. signed written informed consent.

Exclusion Criteria:

1. Attending selected cites

2. Respiratory symptoms defined as cough with or without sputum for more than 2 weeks

3. Evidence or clinical suspicion of active tuberculosis (TB)

4. Current treatment with antituberculous drugs

5. History of having received more than one month's treatment for latent Tuberculosis (LTB) or antituberculous drugs

6. Hypersensitivity or intolerance to isoniazid or rifampicin

7. Active hepatopathy

8. Grade III or higher peripheral neuropathy

9. Chronic alcohol ingestion

10. Contacts of patients with isoniazid or rifampicin drug resistance