Safety of doTBal® in Patients With Tuberculosis: Conduction of an Intensive Pharmacovigilance Program
Launched by LABORATORIOS SILANES S.A. DE C.V. · Jun 1, 2021
Trial Information
Current as of April 27, 2025
Completed
Keywords
ClinConnect Summary
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 conse...
Gender
ALL
Eligibility criteria
- 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.
About Laboratorios Silanes S.A. De C.V.
Laboratorios Silanes S.A. de C.V. is a leading pharmaceutical company dedicated to the research, development, and commercialization of innovative healthcare solutions. With a strong commitment to advancing medical science, the company specializes in the formulation of high-quality pharmaceuticals and biopharmaceuticals that address unmet medical needs. Through rigorous clinical trials and a focus on patient safety and efficacy, Laboratorios Silanes aims to enhance therapeutic options across various therapeutic areas. Their collaborative approach and adherence to international standards underscore their mission to improve health outcomes and contribute to the global healthcare landscape.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Mexico City, , Mexico
Patients applied
Trial Officials
Alberto Maldonado Hernández, MS.
Principal Investigator
Centro de Salud Colima
Martha Castrejón, M.D
Principal Investigator
Centro de Salud Tecomán
José G Maya Campos, M.D
Principal Investigator
Centro Avanzado de Atención Primaria a la Salud
Adara M Cárdenas Sánchez, M.D
Principal Investigator
Centro de Salud Urbano Salangua
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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