DR-TB Clinical Trials Progress Report

Last Updated: April 10, 2017

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Trial Name
Description
Status
Phase
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 enrollmentPhase 2NCT023540142022
STREAM Stage 1Comparison of standard WHO MDR-TB regimen with 9-month modified Bangladesh RegimenEnrollment complete; follow up ongoingPhase 3ISRCTN783721902018
STREAM Stage 2Comparison of a 6 and 9 month bedaquiline-containing regimen against the WHO and Bangladesh regimenOpen for participant enrollmentPhase 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 AfricaPhase 3NCT02454205

PACTR201409000848428
2019
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 AfricaPhase 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 enrolledPhase 2NCT021937762018
DELIBERATE (ACTG 5343)Study of drug-drug interactions and combined QT effects of bedaquiline and delamanidOpen for participant enrollmentPhase 2NCT025830482017
Otsuka 213Safety and efficacy study of delamanid or placebo for 6 months in combination with optimized background therapy for 18-24 monthsStudy completed follow-up for primary endpoint, data analysis ongoingPhase 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 yearsPhase 2NCT018599232019
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 3Phase 1NCT018566342017
ACTG 5312Safety and efficacy study of different doses and generic variants of isoniazid resistant TBCurrently enrolling participants in South AfricaPhase 2NCT019368312017
Opti-QEfficacy and safety study of increased doses of levofloxacin in combination with optimized background therapyFully enrolled in follow upPhase 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 enrollmentPhase 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 VietnamPhase 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 3NCT026074492018
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 contactsOpening in 2017Phase 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 participantsPhase 2NCT023656232018
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 UzbekistanPhase 2-3NCT025897822020
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 GeorgiaPhase 3NCT027547652021