NCT04916899

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

Study to Evaluate the Safety of the Use of doTBal (Rifampicin, Isoniazid, Pyrazinamide and Ethambutol) in Patients With Tuberculosis: Conduction of an Intensive Pharmacovigilance Program

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 47 (actual)
• Sponsor: Laboratorios Silanes S.A. de C.V. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Tuberculosis

Interventions

Type	Name	Description
DRUG	Rifampicin/ Isoniazid/ Pyrazinamide/ Ethambutol	Form: Tablets Dosage: 150 mg / 75 mg / 400 mg / 300 mg Adminstration way: Oral

Timeline

• Start date: 2014-11-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2021-06-08
• Last updated: 2021-06-08

Locations

1 site across 1 country: Mexico