DR-TB Clinical Trial Progress Report

PDF Clinical Trial Progress Report

Last Updated: 17 June 2020
Trial NameDescriptionStatus PhaseTrial Registry Identifier (link)Expected Study Completion Date
Janssen Japan TrialOpen-label, single-arm, multi-center trial to explore safety, efficacy and PK of bedaquiline in Japanese participants with pulmonary MDR-TBCompleted ResultsPhase 2NCT02365623Completed
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 3NCT02333799Completed
Otsuka 232Pharmacokinetic and safety trial of delamanid to determine the appropriate dose for pediatric MDR-TB HIV- patientsCompleted; results pendingPhase 1NCT01856634Completed
Otsuka 233Safety, efficacy, and pharmacokinetic study of delamanid in pediatric patients with MDR-TBCompleted; results pendingPhase 2NCT01859923Completed
NeXTOpen label RCT of a 6-9 month injection free regimen containing bedaquiline, linezolid, levofloxacin, ethionamide/high dose isoniazid, and pyrazinamideEnrollment suspendedPhase 3NCT02454205

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 3ACTRN126160002154262019
Feasibility of Centralized Therapeutic Drug Monitoring of Fluoroquinolones in Multi-Drug Resistant Tuberculosis PatientsObservational, multi-centre, prospective study to investigate the feasibility of centralized TDM of moxifloxacin and levofloxacin in MDR-TB patients by determining turn-around time between sampling and receiving dosing advice.
In addition, the effect of TDM will be evaluated by comparing treatment results of prospective patients receiving TDM with historical controls without TDM.
ACTG 5312Safety and efficacy study of different doses and generic variants of isoniazid resistant TBStage 1 Completed; Stage 2 underwayPhase 2NCT019368312020
DELIBERATE (ACTG 5343)Study of drug-drug interactions and combined QT effects of bedaquiline and delamanidFully enrolled;
Preliminary Results
Phase 2NCT025830482020
Opti-QEfficacy and safety study of increased doses of levofloxacin in combination with optimized background therapyFollow up completed; analysis underway.Phase 2NCT019183972020
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 contactsCompletely enrolled; in follow-upPhase 3ISRCTN926340822020
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.Completely enrolled; in follow-upPhase 3NCT030864862021
IMPAACT PK of Delamanid in ChildrenThe purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of Delamanid 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
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
STREAM Stage 2Comparison of a 6 and 9 month bedaquiline-containing regimen against the WHO and Bangladesh regimenCompletely enrolled; in follow-upPhase 3NCT024092902021
The Individualized M(X) Drug-resistant TB Treatment Strategy Study (InDEX)This is a randomized controlled clinical trial comparing treatment success of a gene-derived individualized drug-resistant Tuberculosis regimen to a standard Tuberculosis regimen based on South African National Tuberculosis guidelines.Currently enrolling participants in South AfricaPhase 4NCT032371822021
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
IMPAACT PK of Bedaquiline in ChildrenThe 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
SimpliciTB DR-TB patients given BPaMZ for 26 weeks (or 6 months)Completely enrolled; in follow-upPhase 2-3NCT033386212022
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
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
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
NGS-Guided(G) Regimens(R) of Anti-tuberculosis(A) Drugs for the Control(C) and Eradication(E) of MDR-TB (GRACE-TB)The purpose of this research is to assess the feasibility and effects of individualized regimen that is guided by rapid molecular drug susceptibility tests of key second-line drugs through next generation sequencing. Meanwhile, the study will evaluate a short course regimens of drugs among "simple MDR-TB" patients who are proven to be sensitive to fluoroquinolones, injectable second-line drugs and pyrazinamide.Not yet recruitingN/A NCT036048482024
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
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