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:
Participant gender:
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
Details
Lead Sponsor:
Instituto Nacional de Salud Publica, Mexico
Collaborators:
Instituto Nacional de Ciencias Medicas y Nutrición Instituto Nacional de Enfermedades Respiratorias