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

Laboratorios Silanes S.A. de C.V.47 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Tuberculosis

Interventions

Rifampicin/ Isoniazid/ Pyrazinamide/ EthambutolDRUG

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

Eligibility

Sex: ALLMin age: 12 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Laboratorio Silanes, S.A. de C.V.

Mexico City, Mexico

Outcomes

Primary Outcomes

To detect adverse events

To detect the adverse events presented during the administration of the drug doTBal®

Time frame: 23 months

Frequency of occurrence of adverse events

Determine the frequency of appearance of each adverse event detected with the administration of the drug doTBal®

Time frame: 23 months

Severity of each of the adverse events

Determine the severity of each of the adverse events during the administration of the drug doTBal®

Time frame: 23 months

Causality of each of the adverse events

Analyze the causality of each of the adverse events detected during the administration of the drug doTBal® (using the Tree-orange algorithm)

Time frame: 23 months

Apparatus and systems affected with adverse events

Analyze the apparatus and systems affected with adverse events during drug administration of doTBal®

Time frame: 23 months

Factors associated with the presentation of adverse events

Analyze other factors associated with the presentation of adverse events during doTBal® administration, such as age, sex, pregnancy, etc.

Time frame: 23 months

Data from ClinicalTrials.gov

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