Bedaquiline
- Generic Name
- Bedaquiline
- Brand Names
- Sirturo
- Drug Type
- Small Molecule
- Chemical Formula
- C32H31BrN2O2
- CAS Number
- 843663-66-1
- Unique Ingredient Identifier
- 78846I289Y
- Background
Bedaquiline is a bactericidal antimycobacterial drug belonging to the class of diarylquinoline. The quinolinic central heterocyclic nucleus with alcohol and amine side chains is responsible for bedaquiline-mediated antimycobacterial activity. Although it is closely related to fluoroquinolones, bedaquiline does not affect DNA gyrase; instead, bedaquiline inhi...
- Indication
Bedaquiline is indicated as part of combination therapy in the treatment of adult and pediatric patients (5 years and older and weighing at least 15 kg) with pulmonary multi-drug resistant tuberculosis (MDR-TB). Reserve SIRTURO for use when an effective treatment regimen cannot otherwise be provided.
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- Associated Conditions
- Pulmonary Multi-Drug Resistant Tuberculosis (MDR-TB)
- Associated Therapies
- -
A Trial to Evaluate the Male Reproductive Safety of Pretomanid in Adult Male Participants With Drug Resistant Pulmonary Tuberculosis Volunteers
- Conditions
- Interventions
- First Posted Date
- 2019-11-27
- Last Posted Date
- 2023-09-13
- Lead Sponsor
- Global Alliance for TB Drug Development
- Target Recruit Count
- 26
- Registration Number
- NCT04179500
- Locations
- 🇿🇦
CHRU, Sizwe Tropical Diseases Hospital, Johannesburg, South Africa
🇿🇦Isango Lethemba TB Research Unit Empilweni TB Hospital, Port Elizabeth, South Africa
🇿🇦The Aurum Institute: Rustenburg Clinical Research Centre, Rustenburg, South Africa
PRACTECAL-PKPD Sub Study
- First Posted Date
- 2019-09-09
- Last Posted Date
- 2021-05-14
- Lead Sponsor
- Medecins Sans Frontieres, Netherlands
- Target Recruit Count
- 240
- Registration Number
- NCT04081077
- Locations
- 🇧🇾
Republican Scientific and Practical Centre for Pulmonology and Tuberculosis hospital, Minsk, Belarus
🇿🇦King DinuZulu Hospital, Durban, KwaZulu-Natal, South Africa
🇿🇦THINK Clinical Trial Unit, Hillcrest, Durban, KwaZulu-Natal, South Africa
Patient-reported Experiences and Quality of Life Outcomes in the TB-PRACTECAL Clinical Trial
- First Posted Date
- 2019-05-08
- Last Posted Date
- 2024-05-29
- Lead Sponsor
- Medecins Sans Frontieres, Netherlands
- Target Recruit Count
- 137
- Registration Number
- NCT03942354
- Locations
- 🇧🇾
Republican Scientific and Practical Centre for Pulmonology and Tuberculosis hospital, Minsk, Belarus
🇺🇿Sh Alimov Republican Specialised Scientific-Practical Medical Centre for Phthysiology and Pulmonology Hospital, Tashkent, Uzbekistan
🇿🇦Helen Jospeh Hospital, Johannesburg, South Africa
Efficacy and Tolerability of Bedaquiline, Delamanid, Levofloxacin, Linezolid, and Clofazimine to Treat MDR-TB
- Conditions
- Interventions
- First Posted Date
- 2019-02-04
- Last Posted Date
- 2024-04-12
- Lead Sponsor
- Boston University
- Target Recruit Count
- 220
- Registration Number
- NCT03828201
- Locations
- 🇻🇳
National Lung Hospital, Hanoi, Vietnam
🇵🇭De La Salle Health Sciences Institute, Dasmariñas, Philippines
A Study to Assess the Drug-Drug Interaction Between Bedaquiline and Clarithromycin in Healthy Adult Participants
- First Posted Date
- 2019-01-11
- Last Posted Date
- 2019-08-28
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 16
- Registration Number
- NCT03800550
- Locations
- 🇧🇪
SGS Life Science Services, Antwerpen, Belgium
Two-month Regimens Using Novel Combinations to Augment Treatment Effectiveness for Drug-sensitive Tuberculosis
- First Posted Date
- 2018-03-22
- Last Posted Date
- 2023-08-14
- Lead Sponsor
- University College, London
- Target Recruit Count
- 675
- Registration Number
- NCT03474198
- Locations
- 🇮🇩
Saiful Anwar Hospital, Malang, Indonesia
🇺🇬Joint Clinical Research Centre, Mbarara, Uganda
🇺🇬Infectious Diseases Institute, Kampala, Uganda
Trial to Evaluate the Efficacy, Safety and Tolerability of BPaMZ in Drug-Sensitive (DS-TB) Adult Patients and Drug-Resistant (DR-TB) Adult Patients
- First Posted Date
- 2017-11-09
- Last Posted Date
- 2024-03-07
- Lead Sponsor
- Global Alliance for TB Drug Development
- Target Recruit Count
- 455
- Registration Number
- NCT03338621
- Locations
- 🇿🇦
University of Cape Town Lung Institute, Cape Town, South Africa
🇿🇦Madibeng Centre for Research, Brits, South Africa
🇿🇦CHRU, Empilweni TB Hospital, Port Elizabeth, South Africa
Various Doses and Durations of Linezolid Plus Bedaquiline & Pretomanid in Participants With Drug Resistant Tuberculosis
- First Posted Date
- 2017-03-22
- Last Posted Date
- 2023-06-29
- Lead Sponsor
- Global Alliance for TB Drug Development
- Target Recruit Count
- 181
- Registration Number
- NCT03086486
- Locations
- 🇿🇦
Tshepong Hospital, Klerksdorp, North - West, South Africa
🇲🇩Institute of Phthisiopneumology Chiril Draganiuc, Chisinau, Moldova, Republic of
🇷🇺Moscow City Research and Practice Tuberculosis Treatment Centre, Moscow, Russian Federation
TASK-002: Bioequivalence of Bedaquiline 400mg Administered in Crushed Form Compared to Tablet Form in Healthy Male and Female Adults Under Fed Conditions (BDQ Crush Study)
- First Posted Date
- 2017-01-26
- Last Posted Date
- 2017-07-28
- Target Recruit Count
- 24
- Registration Number
- NCT03032367
- Locations
- 🇿🇦
TASK Clinical Research Centre, Bellville, Western Cape, South Africa
Evaluating the Pharmacokinetics, Safety, and Tolerability of Bedaquiline in Infants, Children, and Adolescents With Multidrug-Resistant Tuberculosis, Living With or Without HIV
- First Posted Date
- 2016-09-19
- Last Posted Date
- 2024-08-26
- Target Recruit Count
- 84
- Registration Number
- NCT02906007
- Locations
- 🇿🇦
Desmond Tutu TB Centre - Stellenbosch University (DTTC-SU) CRS, Cape Town, Western Cape Province, South Africa
🇿🇦Sizwe CRS, Johannesburg, Gauteng, South Africa
🇭🇹Les Centres GHESKIO Clinical Research Site (GHESKIO-INLR) CRS, Port-au-Prince, Haiti
Drug Development Updates
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