Safety of doTBal® in Patients With Tuberculosis: Conduction of an Intensive Pharmacovigilance Program
Sponsored by Laboratorios Silanes S.A. de C.V.
About this trial
Last updated 4 years ago
Study ID
DoTBal_FVI_001
Status
Completed
Type
Observational
Placebo
No
Accepting
12+ Years
All
Trial Timing
Ended 9 years ago
What is this trial about?
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.
What are the participation requirements?
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.