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

Laboratorios Silanes

Status

Completed

Conditions

Tuberculosis

Treatments

Drug: Rifampicin/ Isoniazid/ Pyrazinamide/ Ethambutol

Study type

Observational

Funder types

Industry

Identifiers

NCT04916899

DoTBal_FVI_001

Details and patient eligibility

About

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.

Full description

The objective of the study was to detect and analyze the adverse events presented during the administration of the drug doTBal® in patients of the Health Centers of the Ministry of Health of the municipalities of Colima, Tecomán and Manzanillo, of the State of Colima. All patients detected in the selected centers that are indicated treatment with doTBal® under the TAES (Strictly Supervised Shortened Treatment) regimen or who are already on this drug (according to their clinical record), will be asked to participate in the study explaining to them the same and requesting their informed consent in writing. In the case of minors, they will also be asked to provide their informed assent.

Enrollment

47 patients

Sex

All

Ages

12+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Patients of both genders with a diagnosis of active pulmonary tuberculosis.
Over 12 years old.
Patients who are being treated with doTBal® under the TAES (Strictly Supervised Shorter Treatment) regimen.
Informed consent (and in the case of minors informed consent) signed.

Exclusion criteria