drugset / Trial / NCT03278483

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

NCT03278483

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2019-02-28
Primary completion
2019-02-28
Completion
2019-02-28

Drugs

EvaluationDrugModalityDoseRoute
Comparator Isoniazid Small molecule 300 mg Oral
Comparator Rifampin Small molecule 600 mg Oral
Comparator Pyridoxine Unknown 50 mg