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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

47 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-30

Study Completion Date

2016-09-30

Brief Summary

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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.

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Detailed Description

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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

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Tuberculosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group A: Rifampicin/ Isoniazid/ Pyrazinamide/ Ethambutol

Pharmaceutical Form: Tablets Dosage: 150 mg / 75 mg / 400 mg / 300 mg Administration way: oral

Rifampicin/ Isoniazid/ Pyrazinamide/ Ethambutol

Intervention Type DRUG

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

Interventions

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Rifampicin/ Isoniazid/ Pyrazinamide/ Ethambutol

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

Intervention Type DRUG

Other Intervention Names

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doTbal®

Eligibility Criteria

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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.