TuberculosisNCT04916899
Safety of doTBal® in Patients With Tuberculosis: Conduction of an Intensive Pharmacovigilance Program
An observational study of Tuberculosis, run by Laboratorios Silanes S.A. de C.V. at 1 site in Mexico.
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. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- What is being tested?
- Rifampicin/ Isoniazid/ Pyrazinamide/ Ethambutol
- Type of treatment
- Pill or oral medicine
- How many people
- 47 participants
- Where
- 1 siteMexico
- Study dates
- Nov 2014to Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients over 12 years old, who are being trated with doTBal® under strictly supervised shorter treatment regimen and sign informes consent.
Who may be able to join
- 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.
Who cannot join
- Withdrawal of informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Tuberculosis
- Being tested
- Rifampicin/ Isoniazid/ Pyrazinamide/ Ethambutol
- Keywords
- Tuberculosis, TB, Tuberculosis treatment, adverse events, pharmacovigilance
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rifampicin/ Isoniazid/ Pyrazinamide/ EthambutolDrug
Also called doTbal®
Form: Tablets Dosage: 150 mg / 75 mg / 400 mg / 300 mg Adminstration way: Oral
| Study group | Role | What they receive |
|---|---|---|
| Group A: Rifampicin/ Isoniazid/ Pyrazinamide/ Ethambutol | Pharmaceutical Form: Tablets Dosage: 150 mg / 75 mg / 400 mg / 300 mg Administration way: oral Receives: Drug: Rifampicin/ Isoniazid/ Pyrazinamide/ Ethambutol |
What is being measured
The primary outcome is the main question the study is designed to answer.
To detect adverse events
To detect the adverse events presented during the administration of the drug doTBal®
Measured: 23 months
Frequency of occurrence of adverse events
Determine the frequency of appearance of each adverse event detected with the administration of the drug doTBal®
Measured: 23 months
Severity of each of the adverse events
Determine the severity of each of the adverse events during the administration of the drug doTBal®
Measured: 23 months
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)
Measured: 23 months
Apparatus and systems affected with adverse events
Analyze the apparatus and systems affected with adverse events during drug administration of doTBal®
Measured: 23 months
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.
Measured: 23 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study startNov 2014
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorios Silanes S.A. de C.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alberto Maldonado Hernández, MS., Principal investigator, Centro de Salud ColimaMartha Castrejón, M.D, Principal investigator, Centro de Salud TecománJosé G Maya Campos, M.D, Principal investigator, Centro Avanzado de Atención Primaria a la SaludAdara M Cárdenas Sánchez, M.D, Principal investigator, Centro de Salud Urbano Salangua
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04916899
- Sponsor's protocol ID
- DoTBal_FVI_001
- Status last verified
- Jun 2021
- First submitted
- 1 Jun 2021
- Last updated
- 8 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 12588714
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04916899
- Acronym / sponsor ID
- DoTBal_FVI_001
- Conditions
- Tuberculosis
- Keywords
- Tuberculosis, TB, Tuberculosis treatment, adverse events, pharmacovigilance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Laboratorios Silanes S.A. de C.V.Industry (pharma, biotech, devices)
- Study start
- Nov 2014 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 8 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group A: Rifampicin/ Isoniazid/ Pyrazinamide/ Ethambutol | – | Drug: Rifampicin/ Isoniazid/ Pyrazinamide/ EthambutolPharmaceutical Form: Tablets Dosage: 150 mg / 75 mg / 400 mg / 300 mg Administration way: oral |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients over 12 years old, who are being trated with doTBal® under strictly supervised shorter treatment regimen and sign informes consent.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Withdrawal of informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rifampicin/ Isoniazid/ Pyrazinamide/ EthambutolAlso: doTbal®Form: Tablets Dosage: 150 mg / 75 mg / 400 mg / 300 mg Adminstration way: Oral | Drug | Group A: Rifampicin/ Isoniazid/ Pyrazinamide/ Ethambutol |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
- Background: PubMed 12588714Blumberg 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.
- NOM-220-SSA1-2016: 2.1.11Link provided by the sponsor.
- Buenas Prácticas de Farmacovigilancia para las Américas, 2008Link provided by the sponsor.
- NORMA Oficial Mexicana NOM-006-SSA2-2013, Para la prevención y control de la tuberculosis.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis, run by Laboratorios Silanes S.A. de C.V. at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To detect adverse events (time frame: 23 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04916899, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2021.