Delamanid

DRUG20 trials

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID), Otsuka Pharmaceutical Development & Commercialization, Inc., Seoul National University Hospital, Médecins Sans Frontières, France, Boston University

Conditions

Drug-resistant TuberculosisExtensively Drug-Resistant TuberculosisHIVHIV InfectionsInfection, BacterialMultidrug Resistant TuberculosisOther Specified Pulmonary TuberculosisPulmonary Tuberculoses

Phase 1

Evaluating 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-TB

CompletedNCT03141060

National Institute of Allergy and Infectious Diseases (NIAID)HIV Infections, Tuberculosis

Start: 2018-01-30End: 2025-05-29Updated: 2025-06-10

Phase 2

A Trial to Evaluate OPC 67683 in Participants With Pulmonary Sputum Culture-positive, Multidrug-resistant Tuberculosis (TB)

CompletedNCT00685360

Otsuka Pharmaceutical Development & Commercialization, Inc.Extensively Drug-Resistant Tuberculosis, Tuberculosis, Multidrug Resistant, Tuberculosis, Pulmonary

Start: 2008-05-08End: 2010-06-11Updated: 2021-12-01

Safety and Pharmacokinetics (PK) in Multidrug-Resistant (MDR) Refractive Tuberculosis

TerminatedNCT01131351

Otsuka Pharmaceutical Development & Commercialization, Inc.Tuberculosis

Start: 2010-02-19End: 2011-05-12Updated: 2021-11-11

A 6-Month Safety, Efficacy, and Pharmacokinetic (PK) Trial of Delamanid in Pediatric Participants With Multidrug Resistant Tuberculosis (MDR-TB)

CompletedNCT01859923

Otsuka Pharmaceutical Development & Commercialization, Inc.Multidrug Resistant Tuberculosis

Start: 2013-07-20End: 2020-01-13Updated: 2020-11-23

A Trial to Evaluate Safety, Tolerability, and Efficacy of Orally Administered OPC-67683

CompletedNCT02573350

Otsuka Pharmaceutical Development & Commercialization, Inc.Tuberculosis, Multidrug-Resistant

Start: 2009-03-26End: 2011-10-27Updated: 2021-11-01

Evaluating the Safety, Tolerability, and Pharmacokinetics of Bedaquiline and Delamanid, Alone and in Combination, For Drug-Resistant Pulmonary Tuberculosis

CompletedNCT02583048

National Institute of Allergy and Infectious Diseases (NIAID)HIV Infections, Tuberculosis

Start: 2016-08-15End: 2021-02-04Updated: 2022-01-27

Treatment Shortening of MDR-TB Using Existing and New Drugs

CompletedNCT02619994

Seoul National University HospitalTuberculosis, Multidrug-Resistant

Start: 2016-01-31End: 2021-06-30Updated: 2025-01-03

Efficacy and Tolerability of Bedaquiline, Delamanid, Levofloxacin, Linezolid, and Clofazimine to Treat MDR-TB

RecruitingNCT03828201

Boston UniversityTuberculosis, Multidrug-Resistant

Start: 2022-06-07End: 2027-05-31Target: 220Updated: 2025-04-27

Early Bactericidal Activity, Safety & Tolerability of Oral GSK3036656 in a Dual Combination With Novel and Established Antitubercular Agents, or Standard of Care in Adults With Rifampicin Susceptible Pulmonary Tuberculosis

CompletedNCT05382312

GlaxoSmithKlineTuberculosis

Start: 2022-07-26End: 2025-05-27Updated: 2025-10-07

Ultra-Short Course Bedaquiline, Clofazimine, Pyrazinamide and Delamanid Versus Standard Therapy for Drug-Susceptible TB

Active, not recruitingNCT05556746

Brigham and Women's HospitalHIV, Tuberculosis, Pulmonary

Start: 2023-11-24End: 2027-01-01Updated: 2026-02-23

Short-course Regimens for the Treatment of Pulmonary Tuberculosis

Active, not recruitingNCT05766267

Centers for Disease Control and PreventionTuberculosis Infection, Tuberculosis, Pulmonary

Start: 2023-11-21End: 2027-12-31Target: 288Updated: 2025-09-19

BTZ-043 Dose Evaluation in Combination and Selection

Michael HoelscherOther Specified Pulmonary Tuberculosis, Tuberculosis, Pulmonary

Start: 2023-09-21End: 2024-08-31Target: 90Updated: 2023-12-22

Clinical Study of JDB0131 Benzenesulfonate Tablets in Patients With Drug-sensitive Pulmonary Tuberculosis

RecruitingNCT06224036

Beijing Chest HospitalDrug-resistant Tuberculosis

Start: 2023-10-31End: 2024-03-31Target: 52Updated: 2024-01-25

Phase 3

Evaluating Newly Approved Drugs for Multidrug-resistant TB

CompletedNCT02754765

Médecins Sans Frontières, FranceInfection, Bacterial, Pulmonary Tuberculoses, Tuberculosis, Multidrug-Resistant

Start: 2016-12-31End: 2023-06-30Updated: 2025-02-10

Efficacy and Tolerability of Delamanid, Linezolid, Pyrazinamide and Levofloxacin

WithdrawnNCT02975570

Boston UniversityTuberculosis Multi Drug Resistant Active

Start: 2017-08-31End: 2022-08-31Updated: 2017-09-11

A5300B/I2003B/PHOENIx

Active, not recruitingPACTR202101800561159

National Institute of Allergy and Infectious Diseases and National Institute of Child Health and Human DevelopmentTuberculosis

Start: 2020-11-02Target: 5610Updated: 2026-01-27

Innovating Shorter, All- Oral, Precised, Individualized Treatment Regimen for Rifampicin Resistant Tuberculosis：Contezolid, Delamanid and Bedaquiline Cohort

Active, not recruitingNCT06081361

Beijing Chest HospitalPulmonary Tuberculosis, Rifampicin-resistant Tuberculosis

Start: 2023-12-22End: 2026-12-31Target: 186Updated: 2025-04-01

Innovating Shorter, All- Oral, Precised Treatment Regimen for Rifampicin Resistant Tuberculosis：BDLL Chinese Cohort

Active, not recruitingNCT06649721

Huashan HospitalDrug-resistant Tuberculosis, Pulmonary Tuberculosis, Rifampin-resistant Tuberculosis

Start: 2024-11-27End: 2027-06-30Target: 120Updated: 2025-09-02

Phase 4

Safety and Effectiveness of Delamanid-containing Regimen for MDR-TB Patients in China

Beijing Chest HospitalMultidrug Resistant Tuberculosis

Start: 2020-07-16End: 2024-07-16Updated: 2022-07-07

Unknown Phase

Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy

CompletedNCT00042289

National Institute of Allergy and Infectious Diseases (NIAID)HIV Infections

Start: 2003-06-09End: 2020-09-30Updated: 2025-12-02

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Delamanid-containing regimens over 24 weeks for the treatment of multidrug-resistant/rifampicin-resistant tuberculosis: preliminary results from a single center in a multicenter, prospective, observational study

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Culture Conversion at 6 Months in Patients Receiving Delamanid-containing Regimens for the Treatment of Multidrug-resistant Tuberculosis

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The endTB observational study protocol: treatment of MDR-TB with bedaquiline or delamanid containing regimens

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Delamanid, linezolid, levofloxacin, and pyrazinamide for the treatment of patients with fluoroquinolone-sensitive multidrug-resistant tuberculosis (Treatment Shortening of MDR-TB Using Existing and New Drugs, MDR-END): study protocol for a phase II/III, multicenter, randomized, open-label clinical trial

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