DR-TB Clinical Trial Progress Report

PDF Clinical Trial Progress Report


Last Updated: 06 January 2020
Trial NameDescriptionStatus PhaseTrial Registry Identifier (link)Expected Study Completion Date
Janssen C211Evaluate the PK, safety, tolerability and anti-mycobacterial activity of Bedaquiline in combination with MDR-TB therapy for HIV uninfected children and adolescents Currently enrolling in Philippines, Russian Federation, and South AfricaPhase 2NCT023540142025
STREAM Stage 2Comparison of a 6 and 9 month bedaquiline-containing regimen against the WHO and Bangladesh regimenOpen for participant enrollment.Phase 3NCT024092902021
NeXTOpen label RCT of a 6-9 month injection free regimen containing bedaquiline, linezolid, levofloxacin, ethionamide/high dose isoniazid, and pyrazinamideEnrollment suspendedPhase 3NCT02454205

NiX-TBStudy of bedaquiline, pretomanid, and linezolid in patients with XDR-TB and MDR-TB for 6 months with an option of 9 monthsCompleted; resultsPhase 3NCT023337992018
DELIBERATE (ACTG 5343)Study of drug-drug interactions and combined QT effects of bedaquiline and delamanidFully Enrolled
Preliminary Results
Phase 2NCT025830482019
Otsuka 233Safety, efficacy, and pharmacokinetic study of delamanid in pediatric patients with MDR-TBFully enrolledPhase 2NCT018599232020
Otsuka 232Pharmacokinetic and safety trial of delamanid to determine the appropriate dose for pediatric MDR-TB HIV- patientsCompleted, results pendingPhase 1NCT018566342019
ACTG 5312Safety and efficacy study of different doses and generic variants of isoniazid resistant TBStage 1 completed; Stage 2 UnderwayPhase 2NCT019368312020
Opti-QEfficacy and safety study of increased doses of levofloxacin in combination with optimized background therapyFollow up completed; analysis underway.Phase 2NCT019183972020
V-QUINEvaluating 6 months daily levofloxacin vs. placebo as preventive therapy in contacts of MDR-TB. Enrolling children, adolescents, infants
HIV+/HIV- Household randomization
Currently enrolling participants in Vietnam.Phase 3ACTRN126160002154262021
MDR-ENDComparing efficacy of a treatment regimen including delamanid, linezolid, levofloxacin, and pyrazinamide for 9-12 months, with a control arm of the standard treatment regimen including injectables for 20-24 months for the treatment of quinolone sensitive MDR-TBCurrently enrolling participants in South Korea.Phase 2NCT026199942021
TB-CHAMPRandomized double blind placebo-controlled, superiority multicenter trial to evaluate the efficacy of levofloxacin vs. placebo for the prevention of MDR-TB in child and adolescent household contactsCurrently enrolling participants in South Africa.Phase 3ISRCTN926340822020
Janssen Japan TrialOpen-label, single-arm, multi-center trial to explore safety, efficacy and PK of bedaquiline in Japanese participants with pulmonary MDR-TBCompleted Preliminary ResultsPhase 2NCT023656232020
TB-PRACTECALMulti-centre, open label, multi-arm, randomized, controlled, phase II-III trial evaluating short treatment regimens containing bedaquiline and pretomanid in combination with existing and re-purposed anti-TB drugs for the treatment of biologically confirmed pulmonary MDR-TBCurrently enrolling participants in Uzbekistan, South Africa, and Belarus.Phase 2-3NCT025897822022
endTBPhase III, randomized, controlled, open-label, non-inferiority, multi-country trial evaluating the efficacy and safety of new combination regimens for MDR-TB treatmentCurrently enrolling participants in Georgia, Peru, Kazakhstan, and Lesotho.Phase 3NCT027547652022
ZeNiXEvaluate the efficacy, safety and tolerability of various doses and durations of linezolid plus bedaquiline and pretomanid after 26 weeks of treatment in participants with either pulmonary XDR-TB, pre-XDR-TB, or treatment intolerant or non-responsive MDR-TB.Currently enrolling participants in Georgia, Republic of Moldova, Russian Federation, South AfricaPhase 3NCT030864862020
SimpliciTB DR-TB patients given BPaMZ for 26 weeks (or 6 months)Currently enrolling patientsPhase 2-3NCT033386212022
IMPAACT 2005 (DAIDS ID 20721)The purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of Delmanid in combination with optimized multidrug background regimen (OBR) for multidrug-resistant tuberculosis (MDR-TB) in HIV-infected and HIV-uninfected children with MDR-TBCurrently enrolling participants in Botswana, India, South Africa and Tanzania Phase 1-2NCT031410602021
P11018 (DAIDS ID 11884)The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of an antituberculosis drug, bedaquiline (BDQ), when used to treat multidrug-resistant tuberculosis (MDR-TB) in HIV-infected and HIV-uninfected infants, children, and adolescents.Currently enrolling non-US participants in Haiti, India and South Africa Phase 1-2NCT029060072022
BEAT-TuberculosisBuilding Evidence for Advancing New Treatment for Rifampicin Resistant Tuberculosis (RR-TB) Comparing a Short Course of Treatment (Containing Bedaquiline, Delamanid and Linezolid) With the Current South African Standard of CareCurrently open for enrollment in South AfricaPhase 3NCT040622012023
ACTG A5300/IMPAACT P2003B (PHOENIx)The purpose of this study is to compare the efficacy and safety of 26 weeks of delamanid (DLM) versus 26 weeks of isoniazid (INH) for preventing confirmed or probable active tuberculosis (TB) during 96 weeks of follow-up among high-risk household contacts (HHCs) of adults with multidrug-resistant tuberculosis (MDR-TB) (index cases). High-risk HHCs are those with HIV or non-HIV immunosuppression, latent TB infection, and young children below the age of 5 years.Enrolling; high-risk infant, child, adolescent, and adult household contacts of individuals with MDR-TBPhase 3 NCT03568383 2025
BEAT-TB (India)Evaluation of the Efficacy and Safety of a Combination regimen of Bedaquiline, Delamanid, Linezolid and Clofazimine in Adults with Pre-extensive (Pre-XDR) and Extensively Drug-resistant Pulmonary Tuberculosis (XDR-TB):Prospective Cohort StudyCurrently open for enrollment in IndiaN/A CTRI/2019/01/017310 2023