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

NCT03278483 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 396

Last updated 2019-04-26

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Isoniazid 300 mg Oral Tablet

Isoniazid tablets 300mg daily plus pyridoxine 50mg daily

DRUG

Rifampin 600 mg Oral Tablet

Rifampin capsules 600mg daily

Sponsors & Collaborators

  • Instituto Nacional de Enfermedades Respiratorias

    collaborator OTHER_GOV

  • Instituto Nacional de Ciencias Medicas y Nutrición

    collaborator UNKNOWN

  • Instituto Nacional de Salud Publica, Mexico

    lead OTHER

Principal Investigators

  • Jose JS Sifuentes -Osornio, Dr · Instituto Nacional de Ciencias Médcias y Nutrición

  • Martha MT Torres-Rojas, DCs · Instituto Nacional de Enfermedades Respiratorias

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03278483 on ClinicalTrials.gov