Clinical trial NCT04916899: Safety of doTBal® in Patients With Tuberculosis: Conduction of an Intensive Pharmacovigilance Program
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tuberculosis
Keywords: Tuberculosis
TB
Tuberculosis treatment
adverse events
pharmacovigilance
Lead sponsor: Laboratorios Silanes S.A. de C.V.
Sponsor class: INDUSTRY
First posted: 2021-06-08
Enrollment: 47
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over 12 years old, who are being trated with doTBal® under strictly supervised shorter treatment regimen and sign informes consent.

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-up with patients will continue for a month after completion of the indicated scheme.

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 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.

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.

Primary outcomes:
measure: To detect adverse events
timeFrame: 23 months
measure: Frequency of occurrence of adverse events
timeFrame: 23 months
measure: Severity of each of the adverse events
timeFrame: 23 months
measure: Causality of each of the adverse events
timeFrame: 23 months
measure: Apparatus and systems affected with adverse events
timeFrame: 23 months
measure: Factors associated with the presentation of adverse events
timeFrame: 23 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Laboratorio Silanes, S.A. de C.V.
Study officials:
affiliation: Centro de Salud Colima
name: Alberto Maldonado Hernández, MS.
role: PRINCIPAL_INVESTIGATOR
affiliation: Centro de Salud Tecomán
name: Martha Castrejón, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Centro Avanzado de Atención Primaria a la Salud
name: José G Maya Campos, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Centro de Salud Urbano Salangua
name: Adara M Cárdenas Sánchez, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Blumberg HM, Burman WJ, Chaisson RE, Daley CL, Etkind SC, Friedman LN, Fujiwara P, Grzemska M, Hopewell PC, Iseman MD, Jasmer RM, Koppaka V, Menzies RI, O'Brien RJ, Reves RR, Reichman LB, Simone PM, Starke JR, Vernon AA; American Thoracic Society, Centers for Disease Control and Prevention and the Infectious Diseases Society. American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of America: treatment of tuberculosis. Am J Respir Crit Care Med. 2003 Feb 15;167(4):603-62. doi: 10.1164/rccm.167.4.603. No abstract available.