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Safety of doTBal® in Patients With Tuberculosis: Conduction of an Intensive Pharmacovigilance Program

NCT04916899 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 47

Last updated 2021-06-08

No results posted yet for this study

Summary

Phase IV, observational, cohort, prospective study. With duration according to the indicated scheme, 6 months of treatment (2 intensive months and 4 months of sotén) for pulmonary tuberculosis. Follow-up with patients will continue for a month after completion of the indicated scheme.

Conditions

Interventions

DRUG

Rifampicin/ Isoniazid/ Pyrazinamide/ Ethambutol

Form: Tablets Dosage: 150 mg / 75 mg / 400 mg / 300 mg Adminstration way: Oral

Sponsors & Collaborators

  • Laboratorios Silanes S.A. de C.V.

    lead INDUSTRY

Principal Investigators

  • Alberto Maldonado Hernández, MS. · Centro de Salud Colima

  • Martha Castrejón, M.D · Centro de Salud Tecomán

  • José G Maya Campos, M.D · Centro Avanzado de Atención Primaria a la Salud

  • Adara M Cárdenas Sánchez, M.D · Centro de Salud Urbano Salangua

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2016-09-30
Completion
2016-09-30

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 NCT04916899 on ClinicalTrials.gov