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OpenTrials
Completed

NCT Number: NCT04916899

Safety of doTBal® 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.

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Key information

Conditions

Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Mycobacterium Infections

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Laboratorio Silanes, S.A. de C.V.

Mexico City, 11000, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rifampicin/ Isoniazid/ Pyrazinamide/ Ethambutol

Drug

Form: Tablets Dosage: 150 mg / 75 mg / 400 mg / 300 mg Adminstration way: Oral

Other names: doTbal®

Primary outcomes

  1. To detect adverse events

    Time frame: 23 months

    To detect the adverse events presented during the administration of the drug doTBal®

  2. 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®

  3. 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®

  4. 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)

  5. 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®

  6. 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.

Sponsors and collaborators

Lead sponsor

Laboratorios Silanes S.A. de C.V.

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jun 8, 2021
Registry last updated
Jun 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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