Ultra-Short Course Bedaquiline, Clofazimine, Pyrazinamide and Delamanid Versus Standard Therapy for Drug-Susceptible TB
Conditions: Tuberculosis, Pulmonary; HIV Interventions: Drug: Bedaquiline; Drug: Clofazimine; Drug: Pyrazinamide; Drug: Delamanid; Drug: Rifampin; Drug: Isoniazid; Drug: Ethambutol Sponsors: Brigham and Women's Hospital; University of Cape Town; Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic; University of Stellenbosch; University of California, Los Angeles; Harvard School of Public Health (HSPH) Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - September 27, 2022 Category: Research Source Type: clinical trials
TB-PRACTECAL: study protocol for a randomised, controlled, open-label, phase II –III trial to evaluate the safety and efficacy of regimens containing bedaquiline and pretomanid for the treatment of adult patients with pulmonary multidrug-resistant tuberculosis
DiscussionTB-PRACTECAL is an ambitious trial using adaptive design to accelerate regimen assessment and bring novel treatments that are effective and safe to patients quicker. The trial took a patient-centred approach, adapting to best practice guidelines throughout recruitment. The implementation faced significant challenges from the COVID-19 pandemic. The trial was terminated early for efficacy on the advice of the DSMB and will report on data collected up to the end of recruitment and, additionally, the planned final analysis at 72 weeks after the end of recruitment.Trial registrationClinicaltrials.gov NCT02589782. Re...
Source: Trials - June 13, 2022 Category: Research Source Type: clinical trials
Keeping up with the guidelines: design changes to the STREAM stage 2 randomised controlled non-inferiority trial for rifampicin-resistant tuberculosis
AbstractResults from the STREAM stage 1 trial showed that a 9-month regimen for patients with rifampicin-resistant tuberculosis was non-inferior to the 20-month regimen recommended by the 2011 WHO treatment guidelines. Similar levels of severe adverse events were reported on both regimens suggesting the need for further research to optimise treatment. Stage 2 of STREAM evaluates two additional short-course regimens, both of which include bedaquiline. Throughout stage 2 of STREAM, new drug choices and a rapidly changing treatment landscape have necessitated changes to the trial ’s design to ensure it remains ethical and r...
Source: Trials - June 7, 2022 Category: Research Source Type: clinical trials
