E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
To compare two treatments for Pulmonary Tuberculosis
Comparar dos tratamientos para la tuberculosis pulmonar |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10037440 |
E.1.2 | Term | Pulmonary tuberculosis |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To compare the antimicrobial activity and safety of standard daily regimen comprised of rifampin (approximately 10 mg/kg/dose) + isoniazid + pyrazinamide + ethambutol (RHZE) to that of an experimental regimen comprised of rifapentine (approximately 10 mg/kg/dose) + isoniazid + pyrazinamide + ethambutol (PHZE).
Comparar la actividad antimicrobiana y la seguridad de una pauta diaria estándar de rifampicina (aproximadamente de 10 mg/Kg/por dosis) + isoniacida + pirazinamida + etambutol (RHZE) frente a una pauta experimental de rifapentina (aproximadamente de 10 mg/Kg/por dosis) + isoniazida + pirazinamida + etambutol (PHZE) |
|
E.2.2 | Secondary objectives of the trial |
To determine and compare? ..the time to culture-conversion. ..patients with adverse reactions. ..the correlation of the liquid culture growth index and other biomarkers with time to culture conversion and treatment failure. ..adverse events and culture conversion rates among HIV-infected vs. HIV-uninfected patients.To store serum for assessment of biomarkers of TB treatment response and hypersensitivity.
Determinar y comparar... ..el tiempo de conversión del cultivo del esputo. ..pacientes con acontecimientos adversos. ..la correlación del crecimiento en los medios líquidos y otros biomarcadores con el tiempo de conversión del cultivo y el fracaso del tratamiento. ..la proporción de los acontecimientos adversos y la tasa de conversión del cultivo entre los pacientes VIH positivos y VIH negativos.Almacenar suero para valoración de biomarcadores de respuesta al tratamiento de la TB y de hipersensibilidad. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Suspected pulmonary tuberculosis. 2. Willingness to have HIV testing performed. 3. 5 (five) or fewer days of multidrug therapy for tuberculosis disease in the 6 months preceding initiation of study drugs. 4. 7 (seven) or fewer days of fluoroquinolone therapy in the 30 days preceding initiation of study drugs. 5. Age > 18 years 6. Karnofsky score of at least 60 7. Signed informed consent 8. Women of child-bearing potential must agree to practice an adequate method of birth control or to abstain from heterosexual intercourse. 9. Laboratory parameters done < 14 days prior to, enrollment: Serum or plasma ALT activity ? 3 times the upper limit of normal Serum or plasma total bilirubin level ? 2.5 times the upper limit of normal Serum or plasma creatinine level ? 2 times the upper limit of normal Complete blood count with hemoglobin level of at least 7.0 g/dL and platelet count of at least 100,000/mm3 Negative pregnancy test
1. Sospecha de tuberculosis pulmonar. 2. Compromiso de acceder a realizarse una prueba de VIH. 3. Cinco (5) o menos días de terapia múltiple anti-tuberculosa en los 6 meses previos a la inclusión. 4. Siete (7) o menos días de tratamiento con una fluoroquinolona durante 30 días previos a la inclusión. 5. Edad mayor de 18 años. 6. puntuación en la escala de Karniosfky de 60 o más 7. Firma del consentimiento informado. 8. Las mujeres en edad fértil deben acceder a usar un método anticonceptivo adecuado o abstenerse de mantener relaciones sexuales heterosexuales. 9. Análisis realizados < 14 días antes del cribado, AST en suero ? 3 veces el límite superior de la normalidad. bilirrubina total en suero £ 2,5 veces el límite superior de la normalidad. Nivel de creatinina en suero £ 2 veces el límite superior de la normalidad. Hemograma completo con nivel de hemoglobina de 7,0 g/dL o superior y recuento de plaquetas de 100.000/mm3 o superior. Prueba de embarazo negativa. |
|
E.4 | Principal exclusion criteria |
1. Pregnant or breast-feeding 2. Known intolerance or allergy to any of the study drugs 3. Concomitant disorders or conditions for which isoniazid, rifamycins, pyrazinamide , or ethambutol are contraindicated. 4. Current or planned therapy, during the intensive phase of TB therapy, with combination antiretroviral therapy for HIV, or with cyclosporine or tacrolimus. 5. Pulmonary silicosis 6. Central nervous system TB 7. Weight < 40 kg
1. Lactancia materna. 2. Intolerancia conocida a cualquiera de los fármacos del estudio. 3. Enfermedad concomitante o condición que contraindique el uso de rifamicinas, isoniacida, pirazinamida o etambutol. 4. Tratamiento antirretroviral actual o previsto durante la fase intensiva del tratamiento antituberculoso o con cicloserina o tacrolimus. Silicosis pulmonar. 5. Tuberculosis del SNC. 6. Peso menor de 40 kg |
|
E.5 End points |
E.5.1 | Primary end point(s) |
1. The proportion of patients, by regimen, having negative sputum cultures at completion of eight weeks (40 doses) of treatment. 2. The proportion of patients, by regimen, who permanently discontinue the assigned study treatment for any reason during the first eight weeks
1. La proporción de pacientes en cada pauta que tienen cultivo de esputo negativos a las 8 semanas (40 dosis) de tratamiento. 2. La proporción de pacientes en cada pauta que discontinúan permanentemente su tratamiento asignado por cualquier razón durante las primeras 8 semanas. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | Yes |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
8 weeks for the intensive treatment phase (study phase) 6 to 9 months for the completion of the treatment |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |