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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: Rifampicin/ Isoniazid/ Pyrazinamide/ Ethambutol | Pharmaceutical Form: Tablets Dosage: 150 mg / 75 mg / 400 mg / 300 mg Administration way: oral |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rifampicin/ Isoniazid/ Pyrazinamide/ Ethambutol | Drug | Form: Tablets Dosage: 150 mg / 75 mg / 400 mg / 300 mg Adminstration way: Oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| To detect adverse events | To detect the adverse events presented during the administration of the drug doTBal® | 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® | 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® | 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) | 23 months |
| Apparatus and systems affected with adverse events | Analyze the apparatus and systems affected with adverse events during drug administration of doTBal® | 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. | 23 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients over 12 years old, who are being trated with doTBal® under strictly supervised shorter treatment regimen and sign informes consent.
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laboratorio Silanes, S.A. de C.V. | Mexico City | 11000 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12588714 | Background | 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. |
| Label | URL |
|---|---|
| NOM-220-SSA1-2016: 2.1.11 | View source |
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| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| ID | Term |
|---|---|
| D012293 | Rifampin |
| D007538 | Isoniazid |
| D011718 | Pyrazinamide |
| D004977 | Ethambutol |
| ID | Term |
|---|---|
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Buenas Prácticas de Farmacovigilancia para las Américas, 2008 | View source |
| NORMA Oficial Mexicana NOM-006-SSA2-2013, Para la prevención y control de la tuberculosis. | View source |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D006834 | Hydrazines |
| D009930 | Organic Chemicals |
| D007539 | Isonicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D011719 | Pyrazines |
| D005029 | Ethylenediamines |
| D003959 | Diamines |
| D011073 | Polyamines |
| D000588 | Amines |