DR-TB Clinical Trials Progress Report

Last Updated: January 19, 2018

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Trial Name
Trial 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 Open for participant enrollment.Phase 2NCT023540142025
STREAM Stage 1Comparison of standard WHO MDR-TB regimen with 9-month modified Bangladesh RegimenEnrollment complete; follow up ongoing.Phase 3ISRCTN783721902018
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 pyrazinamideCurrently enrolling participants in South Africa.Phase 3NCT02454205

NiX-TBStudy of bedaquiline, pretomanid, and linezolid in patients with XDR-TB and MDR-TB for 6 months with an option of 9 monthsCurrently recruiting participants in South Africa.Phase 3NCT023337992021
NC-005Study of combinations of bedaquiline, moxifloxacin, pretomanid, and pyrazinamide for 8 weeks for DS-TB and MDR-TB patients, with one arm for MDR-TB patients adding moxifloxacin to bedaquiline, PA-824 and pyrazinamideFully enrolled.Phase 2NCT021937762018
DELIBERATE (ACTG 5343)Study of drug-drug interactions and combined QT effects of bedaquiline and delamanidOpen for participant enrollment.Phase 2NCT025830482021
Otsuka 213Safety and efficacy study of delamanid or placebo for 6 months in combination with optimized background therapy for 18-24 monthsResults available here.Phase 3NCT014246702017
Otsuka 233Safety, efficacy, and pharmacokinetic study of delamanid in pediatric patients with MDR-TBEnrollment completed for cohorts age 6+ years; enrollment open for cohort age <6 years.Phase 2NCT018599232020
Otsuka 232Pharmacokinetic and safety trial of delamanid to determine the appropriate dose for pediatric MDR-TB HIV- patientsEnrollment completed for cohorts aged 6-11 and 12-17 years; enrollment for cohort aged 3-5 years open, dosing for patients birth to 2 years will be determined from at least 6 patients in group 3.Phase 1NCT018566342018
ACTG 5312Safety and efficacy study of different doses and generic variants of isoniazid resistant TBCurrently enrolling participants in South Africa.Phase 2NCT019368312018
Opti-QEfficacy and safety study of increased doses of levofloxacin in combination with optimized background therapyFollow up completed; analysis underway.Phase 2NCT019183972017
STANDEfficacy, safety and tolerability of a combination of moxifloxacin, pretomanid, and pyrazinamide treatments after 6 months of treatment in subjects with MDR-TB compared to a combination of moxifloxacin, pretomanid, and pyrazinamide treatments in DS-TB subjects; there will be a comparator arm for MDR-TBCurrently on hold; Suspended participant enrollment.Phase 3NCT023428862018
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 2NCT026199942019
FS-1 TrialSafety and efficacy of FS-1 in oral dosage form in drug-resistant pulmonary tuberculosisCurrently enrolling participants in Kazakhstan.Phase 3NCT026074492019
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.Phase 3ISRCTN926340822021
Janssen Japan TrialOpen-label, single-arm, multi-center trial to explore safety, efficacy and PK of bedaquiline in Japanese participants with pulmonary MDR-TBCurrently enrolling participants.Phase 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, Kazakhstan, South Africa, and Belarus.Phase 2-3NCT025897822021
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 3NCT027547652021
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.This study is not yet open for participant recruitment.Phase 3NCT030864862022