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

Overview

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.

Full Title of Study: “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

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: September 2016

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.

Interventions

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

Arms, Groups and Cohorts

  • Group A: Rifampicin/ Isoniazid/ Pyrazinamide/ Ethambutol
    • Pharmaceutical Form: Tablets Dosage: 150 mg / 75 mg / 400 mg / 300 mg Administration way: oral

Clinical Trial Outcome Measures

Primary Measures

  • To detect adverse events
    • Time Frame: 23 months
    • To detect the adverse events presented during the administration of the drug doTBal®
  • Frequency of occurrence of adverse events
    • Time Frame: 23 months
    • Determine the frequency of appearance of each adverse event detected with the administration of the drug doTBal®
  • Severity of each of the adverse events
    • Time Frame: 23 months
    • Determine the severity of each of the adverse events during the administration of the drug doTBal®
  • Causality of each of the adverse events
    • Time Frame: 23 months
    • Analyze the causality of each of the adverse events detected during the administration of the drug doTBal® (using the Tree-orange algorithm)
  • Apparatus and systems affected with adverse events
    • Time Frame: 23 months
    • Analyze the apparatus and systems affected with adverse events during drug administration of doTBal®
  • Factors associated with the presentation of adverse events
    • Time Frame: 23 months
    • Analyze other factors associated with the presentation of adverse events during doTBal® administration, such as age, sex, pregnancy, etc.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 12 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Laboratorios Silanes S.A. de C.V.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • 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

References

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.

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