To compare two treatments for Pulmonary Tuberculosis Comparar dos tratamientos para la tuberculosis pulmonar MedDRA version: 9.1 Level: LLT Classification code 10037440 Term: Pulmonary tuberculosis
Conditions
Interventions
Trade Name: Rifadin
Product Name: Rifadin
Product Code: 0068-0510
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: RIFAMPICIN
CAS Number: 13292461
Concentration unit: mg milligram(s)
Concentrat
Sponsors
TB Investigation Unit of Barcelona
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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);Secondary Objective: 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.;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) | — |
Countries
Spain
Outcome results
None listed