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

Study Overview
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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.

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.

Official Title
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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

Conditions
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Tuberculosis

Intervention / Treatment
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* Drug: Rifampicin/ Isoniazid/ Pyrazinamide/ Ethambutol


Participation Criteria
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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. Exclusion Criteria: Withdrawal of informed consent.

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A: Rifampicin/ Isoniazid/ Pyrazinamide/ Ethambutol<br>Pharmaceutical Form: Tablets Dosage: 150 mg / 75 mg / 400 mg / 300 mg Administration way: oral | Drug: Rifampicin/ Isoniazid/ Pyrazinamide/ Ethambutol<br>* Form: Tablets Dosage: 150 mg / 75 mg / 400 mg / 300 mg Adminstration way: Oral<br>* Other names: doTbal®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To detect adverse events | To detect the adverse events presented during the administration of the drug doTBal® | 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® | 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® | 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) | 23 months | 
| Apparatus and systems affected with adverse events | Analyze the apparatus and systems affected with adverse events during drug administration of doTBal® | 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. | 23 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tuberculosis, TB, Tuberculosis treatment, adverse events, pharmacovigilance