Status:
COMPLETED
Safety of doTBal® in Patients With Tuberculosis: Conduction of an Intensive Pharmacovigilance Program
Lead Sponsor:
Laboratorios Silanes S.A. de C.V.
Conditions:
Tuberculosis
Eligibility:
All Genders
12+ years
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...
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 munic...
Eligibility Criteria
Inclusion
- 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
- Withdrawal of informed consent.
Key Trial Info
Start Date :
November 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT04916899
Start Date
November 1 2014
End Date
September 1 2016
Last Update
June 8 2021
Active Locations (1)
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1
Laboratorio Silanes, S.A. de C.V.
Mexico City, Mexico, 11000