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

Tuberculosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04916899
• Other study ID #: DoTBal_FVI_001
• Status: Completed
• Start date: November 2014
• Est. completion date: September 2016

Study information

• Verified date: June 2021
• Source: Laboratorios Silanes S.A. de C.V.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Tuberculosis

Intervention

Drug:
• Rifampicin/ Isoniazid/ Pyrazinamide/ Ethambutol
Form: Tablets Dosage: 150 mg / 75 mg / 400 mg / 300 mg Adminstration way: Oral

Locations

Country	Name	City	State
Mexico	Laboratorio Silanes, S.A. de C.V.	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Laboratorios Silanes S.A. de C.V.

Country where clinical trial is conducted

Mexico, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To detect adverse events	To detect the adverse events presented during the administration of the drug doTBal®	23 months
Primary	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
Primary	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
Primary	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
Primary	Apparatus and systems affected with adverse events	Analyze the apparatus and systems affected with adverse events during drug administration of doTBal®	23 months
Primary	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

External Links

•   Buenas Prácticas de Farmacovigilancia para las Américas, 2008
•   NOM-220-SSA1-2016: 2.1.11
•   NORMA Oficial Mexicana NOM-006-SSA2-2013, Para la prevención y control de la tuberculosis.