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
- -
Evaluating Newly Approved Drugs for Multidrug-resistant TB
- First Posted Date
- 2016-04-28
- Last Posted Date
- 2024-07-24
- Lead Sponsor
- Médecins Sans Frontières, France
- Target Recruit Count
- 754
- Registration Number
- NCT02754765
- Locations
- 🇵🇪
Hospital Nacional Dos de Mayo Parque Historia de la Medicina, Lima, Peru
🇰🇿National Center for Tuberculosis Problems, Almaty, Kazakhstan
🇬🇪National Center for Tuberculosis and Lung Diseases, Tbilisi, Georgia
Pragmatic Clinical Trial for a More Effective Concise and Less Toxic MDR-TB Treatment Regimen(s)
- Conditions
- Interventions
- First Posted Date
- 2015-10-28
- Last Posted Date
- 2024-05-01
- Lead Sponsor
- Medecins Sans Frontieres, Netherlands
- Target Recruit Count
- 552
- Registration Number
- NCT02589782
- Locations
- 🇿🇦
King DinuZulu Hospital, Durban, KwaZulu-Natal, South Africa
🇺🇿Republican TB Hospital No. 2, Nukus, Karakalpakstan, Uzbekistan
🇧🇾Republican Scientific and Practical Centre for Pulmonology and Tuberculosis hospital, Minsk, Belarus
Evaluating the Safety, Tolerability, and Pharmacokinetics of Bedaquiline and Delamanid, Alone and in Combination, For Drug-Resistant Pulmonary Tuberculosis
- Conditions
- Interventions
- First Posted Date
- 2015-10-21
- Last Posted Date
- 2022-01-27
- Target Recruit Count
- 84
- Registration Number
- NCT02583048
- Locations
- 🇵🇪
Barranco CRS, Lima, Peru
🇿🇦Task Applied Science (TASK) CRS, Cape Town, Western Cape Province, South Africa
🇿🇦South African Tuberculosis Vaccine Initiative (SATVI) CRS, Cape Town, Western Cape Province, South Africa
An Open-label RCT to Evaluate a New Treatment Regimen for Patients With Multi-drug Resistant Tuberculosis
- First Posted Date
- 2015-05-27
- Last Posted Date
- 2021-09-29
- Lead Sponsor
- University of Cape Town
- Target Recruit Count
- 154
- Registration Number
- NCT02454205
- Locations
- 🇿🇦
Brooklyn Chest Hospital, Cape Town, Western Cape, South Africa
The Evaluation of a Standard Treatment Regimen of Anti-tuberculosis Drugs for Patients With MDR-TB
- First Posted Date
- 2015-04-06
- Last Posted Date
- 2023-09-28
- Lead Sponsor
- IUATLD, Inc
- Target Recruit Count
- 588
- Registration Number
- NCT02409290
- Locations
- 🇪🇹
Armauer Hanssen Research Institute, Addis Ababa, Ethiopia
🇪🇹St. Peter's Tuberculosis Specializes Hospital, Addis Ababa, Ethiopia
🇬🇪JSC National Center for Tuberculosis and Lung Diseases, Tbilisi, Georgia
A Phase 3 Study Assessing Safety and Efficacy of Bedaquiline Plus PA-824 Plus Linezolid in Subjects With Drug Resistant Pulmonary Tuberculosis
- Conditions
- Interventions
- First Posted Date
- 2015-01-07
- Last Posted Date
- 2024-08-09
- Lead Sponsor
- Global Alliance for TB Drug Development
- Target Recruit Count
- 109
- Registration Number
- NCT02333799
- Locations
- 🇿🇦
Task Applied Science - Brooklyn Chest Hospital, Ysterplaat, Cape Town, South Africa
🇿🇦King DinuZulu Hospital Complex, Sydenham, Durban, South Africa
🇿🇦Sizwe Tropical Disease Hospital, Sandringham, Johannesburg, South Africa
A Phase 2 to Evaluate the Efficacy, Safety and Tolerability of Combinations of Bedaquiline, Moxifloxacin, PA-824 and Pyrazinamide in Adult Subjects With Drug-Sensitive or Multi Drug-Resistant Pulmonary Tuberculosis.
- Conditions
- Interventions
- First Posted Date
- 2014-07-18
- Last Posted Date
- 2019-07-26
- Lead Sponsor
- Global Alliance for TB Drug Development
- Target Recruit Count
- 240
- Registration Number
- NCT02193776
- Locations
- 🇿🇦
Klerksdorp Tshepong Hospital, Jouberton, Klerksdorp, South Africa
🇿🇦The Aurum Institute: Tembisa Hospital, Tembisa, Gauteng, South Africa
🇹🇿NIMR-Mbeya Medical Research Centre (MMRC), Mbeya, Tanzania
Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy
- Conditions
- Interventions
- Drug: darunavir/ritonavir dosage #1Drug: TAF w/cobicistatDrug: TAF w/cobicistat or ritonavirDrug: tenofovir alafenamide fumarate (TAF)Drug: elvitegravir/cobicistatDrug: darunavir/cobicistatDrug: atazanavir/cobicistatDrug: lopinavir/ritonavir dosage #1Drug: atazanavir/ritonavir/tenofovir dosage #1Drug: lopinavir/ritonavir dosage #2Drug: indinavir/ritonavir dosage #1Drug: fosamprenavir/ritonavirDrug: atazanavir/ritonavir dosage #1Drug: didanosine delayed release (Videx® EC)Drug: emtricitabineDrug: nelfinavir dosage #1Drug: tipranavir/ritonavirDrug: etravirineDrug: darunavir/ritonavir dosage #4Drug: indinavir/ritonavir dosage #2Drug: rilpivirineDrug: ethambutolDrug: efavirenzDrug: raltegravirDrug: dolutegravirDrug: kanamycinDrug: nevirapineDrug: amprenavirDrug: abacavirDrug: tenofovirDrug: maravirocDrug: darunavir/ritonavir dosage #2Drug: lopinavir/ritonavir dosage #3Drug: lopinavir/ritonavir dosage #4Drug: tenofovir/atazanavir/ritonavir dosage #2Drug: atazanavir/ritonavir dosage #2Drug: nelfinavir dosage #2Drug: rifampicinDrug: amikacinDrug: darunavir/ritonavir dosage #3Drug: etonogestrel implantDrug: capreomycinDrug: ethinyl estradiolDrug: isoniazidDrug: moxifloxacinDrug: levoflaxacinDrug: pyrazinamideDrug: ofloxacinDrug: ethionamide/prothionamideDrug: terizidone/cycloserineDrug: para-aminosalicylic acid (PAS)Drug: high dose INHDrug: bedaquilineDrug: clofazamineDrug: delamanidDrug: linezolidDrug: pretomanid
- First Posted Date
- 2002-08-01
- Last Posted Date
- 2022-07-22
- Target Recruit Count
- 1578
- Registration Number
- NCT00042289
- Locations
- 🇺🇸
Usc La Nichd Crs, Los Angeles, California, United States
🇿🇦Wits RHI Shandukani Research Centre CRS, Johannesburg, Gauteng, South Africa
🇺🇸Boston Medical Center Ped. HIV Program NICHD CRS, Boston, Massachusetts, United States
Drug Development Updates
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