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

June 1, 2021 updated by: Laboratorios Silanes S.A. de C.V.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

47

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Mexico City, Mexico, 11000
        • Laboratorio Silanes, S.A. de C.V.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group A: Rifampicin/ Isoniazid/ Pyrazinamide/ Ethambutol
Pharmaceutical Form: Tablets Dosage: 150 mg / 75 mg / 400 mg / 300 mg Administration way: oral
Drug: Rifampicin/ Isoniazid/ Pyrazinamide/ Ethambutol
Form: Tablets Dosage: 150 mg / 75 mg / 400 mg / 300 mg Adminstration way: Oral
Other Names:
  • doTbal®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To detect adverse events
Time Frame: 23 months
To detect the adverse events presented during the administration of the drug doTBal®
23 months
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®
23 months
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®
23 months
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)
23 months
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®
23 months
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.
23 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laboratorios Silanes S.A. de C.V.

Investigators

  • Principal Investigator: Alberto Maldonado Hernández, MS., Centro de Salud Colima
  • Principal Investigator: Martha Castrejón, M.D, Centro de Salud Tecomán
  • Principal Investigator: José G Maya Campos, M.D, Centro Avanzado de Atención Primaria a la Salud
  • Principal Investigator: Adara M Cárdenas Sánchez, M.D, Centro de Salud Urbano Salangua

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2014

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

June 1, 2021

First Submitted That Met QC Criteria

June 1, 2021

First Posted (Actual)

June 8, 2021

Study Record Updates

Last Update Posted (Actual)

June 8, 2021

Last Update Submitted That Met QC Criteria

June 1, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DoTBal_FVI_001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Tuberculosis

Clinical Trials on Rifampicin/ Isoniazid/ Pyrazinamide/ Ethambutol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kuwait

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe