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

Completed

• Conditions: Tuberculosis
• Interventions: Drug: Rifampicin/ Isoniazid/ Pyrazinamide/ Ethambutol

• Registration Number: NCT04916899
• Lead Sponsor: Laboratorios Silanes S.A. de C.V.

Brief 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.

Study Timeline

• Study Start: 2014-11
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2021-06
• Study First Submitted: 2021-06-01
• Study First Submitted QC: 2021-06-01
• Last Update Submitted: 2021-06-01
• Study First Posted: 2021-06-08
• Last Update Posted: 2021-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

• Withdrawal of informed consent.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group A: Rifampicin/ Isoniazid/ Pyrazinamide/ Ethambutol	Rifampicin/ Isoniazid/ Pyrazinamide/ Ethambutol	Pharmaceutical Form: Tablets Dosage: 150 mg / 75 mg / 400 mg / 300 mg Administration way: oral

Primary Outcome Measures

Name	Time	Method
Factors associated with the presentation of adverse events	23 months	Analyze other factors associated with the presentation of adverse events during doTBal® administration, such as age, sex, pregnancy, etc.
To detect adverse events	23 months	To detect the adverse events presented during the administration of the drug doTBal®
Frequency of occurrence of adverse events	23 months	Determine the frequency of appearance of each adverse event detected with the administration of the drug doTBal®
Severity of each of the adverse events	23 months	Determine the severity of each of the adverse events during the administration of the drug doTBal®
Causality of each of the adverse events	23 months	Analyze the causality of each of the adverse events detected during the administration of the drug doTBal® (using the Tree-orange algorithm)
Apparatus and systems affected with adverse events	23 months	Analyze the apparatus and systems affected with adverse events during drug administration of doTBal®

Trial Locations

Locations (1)

Laboratorio Silanes, S.A. de C.V.; 🇲🇽 Mexico City, Mexico