A pragmatic randomized controlled trial to evaluate the efficacy and safety of an oral short-course regimen including bedaquiline for the treatment of patients with multidrug-resistant tuberculosis in China: study protocol for PROSPECT
DiscussionPROSPECT aims to assess the safety and efficacy of a BDQ-containing SCR MDR-TB treatment at seventeen sites across China, while also providing high-quality data to guide SCRs administration under the direction of the China National Tuberculosis Program for MDR-TB. Additionally, PROSPECT will explore the potential benefits of extending the administration of the 9-month BDQ-containing SCR for participants without sputum conversion by week 16.Trial registrationClinicalTrials.gov NCT05306223. Prospectively registered on 16 March 2022 athttps://clinicaltrials.gov/ct2/show/NCT05306223?term=NCT05306223&draw=1&ra...
Source: Trials - April 1, 2024 Category: Research Source Type: clinical trials
Quabodepistat in combination with delamanid and bedaquiline in participants with drug-susceptible pulmonary tuberculosis: protocol for a multicenter, phase 2b/c, open-label, randomized, dose-finding trial to evaluate safety and efficacy
The objective of this study is to evaluate the safety, efficacy, and appropriate dosing of a 4-month regimen of QBS in combination with delamanid and bedaquiline in participants with drug-susceptible pulmonary TB in comparison with the 6-month standard treatment (i.e., rifampicin, isoniazid, ethambutol, and pyrazinamide).MethodsThis phase 2b/c, open-label, randomized, parallel group, dose-finding trial will enroll approximately 120 participants (including no more than 15% with human immunodeficiency virus [HIV] coinfection) aged ≥ 18 to ≤ 65 years at screening with newly diagnosed pulmonary drug-sensitive TB from ~8 si...
Source: Trials - January 19, 2024 Category: Research Source Type: clinical trials
A Randomized, Adaptive, Dose-Ranging, Open-Label Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis
Conditions: Pulmonary Tuberculosis Interventions: Drug: Isoniazid; Drug: Rifampicin; Drug: Pyrazinamide; Drug: Ethambutol; Drug: Bedaquiline; Drug: Pretomanid; Drug: Linezolid; Drug: TBI-223; Drug: Sutezolid Sponsors: National Institute of Allergy and Infectious Diseases (NIAID) Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - January 5, 2024 Category: Research Source Type: clinical trials
Adaptive evaluation of mHealth and conventional adherence support interventions to optimize outcomes with new treatment regimens for drug-resistant tuberculosis and HIV in South Africa (ADAP-TIV): study protocol for an adaptive randomized controlled trial
DiscussionThis trial will evaluate the contribution of different modes of adherence support on MDR-TB and HIV outcomes with WHO-recommended all-oral MDR-TB regimens and ART in a high-burden operational setting. We will also assess the utility of a DSD framework to pragmatically adjust levels of MDR-TB and HIV treatment support.Trial registrationClinicalTrials.gov NCT05633056. Registered on 1 December 2022 (Source: Trials)
Source: Trials - December 1, 2023 Category: Research Source Type: clinical trials
Evaluating newly approved drugs in combination regimens for multidrug-resistant tuberculosis with fluoroquinolone resistance (endTB-Q): study protocol for a multi-country randomized controlled trial
DiscussionThis internally controlled study of shortened treatment for pre-XDR TB will provide urgently needed data and evidence for clinical and policy decision-making around the treatment of pre-XDR TB with a four-drug, all-oral, shortened regimen.Trial registrationClinicalTrials.Gov NCT03896685. Registered on 1 April 2018; the record was last updated for study protocol version 4.3 on 17 March 2023. (Source: Trials)
Source: Trials - November 30, 2023 Category: Research Source Type: clinical trials
Platform Assessing Regimens and Durations In a Global Multisite Consortium for TB
Conditions: Pulmonary Tuberculosis Interventions: Drug: GSK3036656; Drug: BTZ-043; Drug: Bedaquiline (B); Drug: Delamanid (D); Drug: Pretomanid (Pa); Drug: Moxifloxacin (M); Drug: Linezolid (L); Drug: Pyrazinamide (Z); Drug: Rifampicin (R); Drug: Isoniazid (H); Drug: Ethambutol (E) Sponsors: University College, London; Radboud University Medical Center; London School of Hygiene and Tropical Medicine; University of Oxford; Research Center Borstel; Lygature; TASK Applied Science; Vita-Salute San Raffaele University; Helmholtz Zentrum Munchen; KNCV Tuberculosis Foundation; Critical Path Institute; European Lung Foundation; In...
Source: ClinicalTrials.gov - November 2, 2023 Category: Research Source Type: clinical trials
Innovating Shorter, All- Oral, Precised, Individualized Treatment Regimen for Rifampicin Resistant Tuberculosis ：Contizolid and Dlamanid Cohort
Conditions: Pulmonary Tuberculosis; Rifampicin-resistant Tuberculosis Interventions: Drug: Bedaquiline; Drug: Delamanid; Drug: Contezolid; Drug: Levofloxacin; Drug: Moxifloxacin; Drug: Clofazimine; Drug: Linezolid; Drug: Cycloserine; Drug: Prothionamide; Drug: Pyrazinamide; Drug: Para-Aminosalicylic Acid; Drug: Ethambutol Sponsors: Beijing Chest Hospital Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - October 13, 2023 Category: Research Source Type: clinical trials
Phase 2 Trial Assessing TBAJ876 or Bedaquiline, With Pretomanid and Linezolid in Adults With Drug-sensitive Pulmonary Tuberculosis
Conditions: Pulmonary TB; Pulmonary Tuberculosis; Drug Sensitive Tuberculosis Interventions: Drug: TBAJ-876; Drug: Pretomanid; Drug: Linezolid; Drug: Bedaquiline; Drug: HRZE; Drug: HR Sponsor: Global Alliance for TB Drug Development Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - September 28, 2023 Category: Research Source Type: clinical trials
Phase 2 Trial Assessing TBAJ876 or Bedaquiline, With Pretomanid and Linezolid in Adults With Drug-sensitive Pulmonary Tuberculosis
Conditions: Pulmonary TB; Pulmonary Tuberculosis; Drug Sensitive Tuberculosis Interventions: Drug: TBAJ-876; Drug: Pretomanid; Drug: Linezolid; Drug: Bedaquiline; Drug: HRZE; Drug: HR Sponsors: Global Alliance for TB Drug Development Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - September 28, 2023 Category: Research Source Type: clinical trials
Efficacy and Safety Evaluation of Two to Four Months of Treatment With the Combination Regimens of DBOS and PBOS in Adults With Pulmonary Tuberculosis
Condition: Pulmonary Tuberculosis Interventions: Drug: Delamanid, Bedaquiline, OPC-167832, and Sutezolid (DBOS); Drug: Pretomanid, Bedaquiline, OPC-167832, and Sutezolid (PBOS); Drug: Isoniazid, Rifampicin, Pyrazinamide, Ethambutol (HRZE); Drug: Pretomanid or Delamanid, Bedaquiline, OPC-167832, and Sutezolid (XBOS) Sponsors: Bill & Melinda Gates Medical Research Institute; Global Alliance for TB Drug Development; Janssen Pharmaceutica; Otsuka Pharmaceutical Co., Ltd. Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - August 2, 2023 Category: Research Source Type: clinical trials
