Trial to Evaluate the Efficacy, Safety and Tolerability of BPaMZ in Drug-Sensitive (DS-TB) Adult Patients and Drug-Resistant (DR-TB) Adult Patients
NCT ID: NCT03338621
Last Updated: 2024-03-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
455 participants
INTERVENTIONAL
2018-07-30
2022-06-10
Brief Summary
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Detailed Description
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All participants in the below arms will have follow-up for a period of 104 weeks (24 months) from the start of therapy.
Participants with Drug Sensitive TB (DS-TB):
Participants with DS-TB will be randomized to one of two treatment arms. These participants will receive either BPaMZ daily for 17 weeks (4 months), or HRZE/HR combination tablets daily for 26 weeks (6 months). participants will be stratified for co-infection with human immunodeficiency virus (HIV) and cavitation.
Participants with Drug Resistant TB (DR-TB):
Participants with DR-TB will be assigned to receive BPaMZ daily for 26 weeks (6 months).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Drug Sensitive BPaMZ
Bedaquiline 200 mg daily for 8 weeks then 100 mg daily for 9 weeks, together with pretomanid 200 mg + moxifloxacin 400 mg + pyrazinamide 1500 mg daily for 17 weeks (Total treatment duration 4 months
Pretomanid
200 mg tablets
Bedaquiline
100 mg tablets
Moxifloxacin
400 mg tablets
Pyrazinamide
500 mg tablets
Drug Sensitive Standard Treatment
isoniazid 75 mg + rifampicin 150 mg + pyrazinamide 400 mg + ethambutol 275 mg (HRZE) combination tablets for 8 weeks AND isoniazid 75 mg + rifampicin 150 mg (HR) combination tablets for Weeks 9 to 26
HRZE
isoniazid 75 mg plus rifampicin 150 mg plus pyrazinamide 400 mg plus ethambutol 275 mg combination tablets
HR
isoniazid 75 mg plus rifampicin 150 mg combination tablets
Drug Resistant BPaMZ
Bedaquiline 200 mg daily for 8 weeks then 100 mg daily for 18 weeks, together with pretomanid 200 mg + moxifloxacin 400 mg + pyrazinamide 1500 mg daily for 26 weeks (Total treatment duration 6 months)
Pretomanid
200 mg tablets
Bedaquiline
100 mg tablets
Moxifloxacin
400 mg tablets
Pyrazinamide
500 mg tablets
Interventions
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Pretomanid
200 mg tablets
Bedaquiline
100 mg tablets
Moxifloxacin
400 mg tablets
Pyrazinamide
500 mg tablets
HRZE
isoniazid 75 mg plus rifampicin 150 mg plus pyrazinamide 400 mg plus ethambutol 275 mg combination tablets
HR
isoniazid 75 mg plus rifampicin 150 mg combination tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants with one of the following pulmonary TB conditions:
DS-TB treatment arm participants should be:
* sensitive to rifampicin and isoniazid by rapid sputum based test AND
* either newly diagnosed for TB or have a history of being untreated for at least 3 years after cure from a previous episode of TB.
DR-TB treatment arm participants should be Resistant to rifampicin and/or isoniazid.
* Of non-childbearing potential or willing to practice effective methods of birth control
* Body weight (in light clothing and no shoes) ≥ 30 kg.
* Completed informed consent form
Exclusion Criteria
* Any risk factor for QT prolongation
* Any planned contraindicated medicines
* Resistant to fluoroquinolones (rapid, sputum-based molecular screening tests).
Any of the following lab toxicities/abnormalities:
* CD4+ count \< 100 cells/µL (HIV infected participants)
* platelets \<75,000/mm³
* creatinine \>1.5 times upper limit of normal (ULN)
* eGFR ≤ 60 mL/min
* haemoglobin \<8.0 g/dL
* serum potassium less than the lower limit of normal for the laboratory.
* GGT: greater than 3 x ULN
* AST: ≥3.0 x ULN to be excluded;
* ALT: ≥3.0 x ULN to be excluded
* ALP: ≥3.0 x ULN to be excluded
* Total bilirubin: \>1.5 x ULN to be excluded;
* Direct bilirubin: greater than 1x ULN to be excluded
18 Years
ALL
No
Sponsors
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Global Alliance for TB Drug Development
OTHER
Responsible Party
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Principal Investigators
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Morounfolu Olugbosi, MD MSc
Role: STUDY_CHAIR
Global Alliance for TB Drug Development
Locations
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Evandro Chagas
Rio de Janeiro, , Brazil
FIOCRUZ
Rio de Janeiro, , Brazil
National Center for Tuberculosis and Lung Diseases
Tbilisi, , Georgia
Institut Perubatan Respiratori
Kuala Lumpur, , Malaysia
Lung Center of Philippines
Manila, , Philippines
Tropical Disease Foundation
Manila, , Philippines
Moscow City Research and Practice Tuberculosis Treatment Centre
Moscow, , Russia
Central TB Research Institute of the Federal Agency of Scientific Organizations
Moscow, , Russia
Research Institute of Phthisiopulmonology of I. M. Sechenov First Moscow State Medical University
Moscow, , Russia
Research Institute of the Phthisiopulmonology
Saint Petersburg, , Russia
Ural Research Institute of Phthisiopulmonology
Yekaterinburg, , Russia
THINK
Pietermaritzburg, KwaZulu-Natal, South Africa
Madibeng Centre for Research
Brits, , South Africa
TASK
Cape Town, , South Africa
University of Cape Town Lung Institute
Cape Town, , South Africa
Enhancing Care Foundation
Durban, , South Africa
CHRU, King Dinuzulu
Durban, , South Africa
CHRU, Helen Joseph Hospital
Johannesburg, , South Africa
PHRU, Tshepong Hospital
Klerksdorp, , South Africa
CHRU, Empilweni TB Hospital
Port Elizabeth, , South Africa
Setshaba Research Centre
Soshanguve, , South Africa
Ifakara Health Institute
Bagamoyo, , Tanzania
NIMR-Mbeya
Mbeya, , Tanzania
Kilimanjaro Clinical Research Institute
Moshi, , Tanzania
Mwanza Intervention Trials Unit
Mwanza, , Tanzania
Case Western Reserve University
Kampala, , Uganda
Countries
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References
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Cevik M, Thompson LC, Upton C, Rolla VC, Malahleha M, Mmbaga B, Ngubane N, Abu Bakar Z, Rassool M, Variava E, Dawson R, Staples S, Lalloo U, Louw C, Conradie F, Eristavi M, Samoilova A, Skornyakov SN, Ntinginya NE, Haraka F, Praygod G, Mayanja-Kizza H, Caoili J, Balanag V, Dalcolmo MP, McHugh T, Hunt R, Solanki P, Bateson A, Crook AM, Fabiane S, Timm J, Sun E, Spigelman M, Sloan DJ, Gillespie SH; SimpliciTB Consortium. Bedaquiline-pretomanid-moxifloxacin-pyrazinamide for drug-sensitive and drug-resistant pulmonary tuberculosis treatment: a phase 2c, open-label, multicentre, partially randomised controlled trial. Lancet Infect Dis. 2024 Sep;24(9):1003-1014. doi: 10.1016/S1473-3099(24)00223-8. Epub 2024 May 17.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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SimpliciTB (B-Pa-M-Z) NC-008
Identifier Type: -
Identifier Source: org_study_id
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