Tuberculosis Clinical Trial
Official title:
An Open-Label, Partially Randomized Trial to Evaluate the Efficacy, Safety and Tolerability of a 4-month Treatment of Bedaquiline Plus Pretomanid Plus Moxifloxacin Plus Pyrazinamide (BPaMZ) Compared to a 6-month Treatment of HRZE/HR (Control) in Adult Participants With Drug-Sensitive Smear-Positive Pulmonary Tuberculosis (DS-TB) and a 6-month Treatment of BPaMZ in Adult Participants With Drug Resistant, Smear-Positive Pulmonary Tuberculosis (DR-TB)
Verified date | March 2024 |
Source | Global Alliance for TB Drug Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To evaluate the efficacy, safety and tolerability at 8 weeks (2-months), 52 weeks (12-months), and 104 Weeks (24-months) post the start of the following treatment regimens in participants with: Drug Sensitive TB (DS-TB) patients given BPaMZ for 17 Weeks ( or 4 months) vs. Standard HRZE/HR treatment given for 26 weeks (or 6 months) and Drug Resistant TB (DR-TB) patients given BPaMZ for 26 Weeks (or 6 months)
Status | Completed |
Enrollment | 455 |
Est. completion date | June 10, 2022 |
Est. primary completion date | July 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Sputum positive for tubercule bacilli (at least 1+ on the International Union Against Tuberculosis and Lung Disease [IUATLD]/WHO scale (Appendix 1) on smear microscopy) at the trial laboratory. - 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: - Karnofsky score <60% - 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 |
Country | Name | City | State |
---|---|---|---|
Brazil | Evandro Chagas | Rio de Janeiro | |
Brazil | FIOCRUZ | Rio de Janeiro | |
Georgia | National Center for Tuberculosis and Lung Diseases | Tbilisi | |
Malaysia | Institut Perubatan Respiratori | Kuala Lumpur | |
Philippines | Lung Center of Philippines | Manila | |
Philippines | Tropical Disease Foundation | Manila | |
Russian Federation | Central TB Research Institute of the Federal Agency of Scientific Organizations | Moscow | |
Russian Federation | Moscow City Research and Practice Tuberculosis Treatment Centre | Moscow | |
Russian Federation | Research Institute of Phthisiopulmonology of I. M. Sechenov First Moscow State Medical University | Moscow | |
Russian Federation | Research Institute of the Phthisiopulmonology | Sankt Petersburg | |
Russian Federation | Ural Research Institute of Phthisiopulmonology | Yekaterinburg | |
South Africa | Madibeng Centre for Research | Brits | |
South Africa | TASK | Cape Town | |
South Africa | University of Cape Town Lung Institute | Cape Town | |
South Africa | CHRU, King Dinuzulu | Durban | |
South Africa | Enhancing Care Foundation | Durban | |
South Africa | CHRU, Helen Joseph Hospital | Johannesburg | |
South Africa | PHRU, Tshepong Hospital | Klerksdorp | |
South Africa | THINK | Pietermaritzburg | KwaZulu Natal |
South Africa | CHRU, Empilweni TB Hospital | Port Elizabeth | |
South Africa | Setshaba Research Centre | Soshanguve | |
Tanzania | Ifakara Health Institute | Bagamoyo | |
Tanzania | NIMR-Mbeya | Mbeya | |
Tanzania | Kilimanjaro Clinical Research Institute | Moshi | |
Tanzania | Mwanza Intervention Trials Unit | Mwanza | |
Uganda | Case Western Reserve University | Kampala |
Lead Sponsor | Collaborator |
---|---|
Global Alliance for TB Drug Development |
Brazil, Georgia, Malaysia, Philippines, Russian Federation, South Africa, Tanzania, Uganda,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Culture Negative Status by 8 Weeks | Culture negative status is achieved when a participant produces at least two negative culture results at different visits (at least 7 days apart) without an intervening positive culture result for M.tb. | Days 0-56 (8 weeks) | |
Secondary | Number of Participants With Bacteriologic Failure or Relapse or Clinical Failure (Unfavorables) at 52 Weeks From Start of Therapy (12 Months) | Unfavorable status:
Participants not classified as having achieved or maintained culture negative status when last seen Participants previously classified as having culture negative status who, following the end of treatment, have two positive cultures without an intervening negative culture Participants who had a positive culture not followed by at least two negative cultures when last seen Participants dying from any cause during treatment, except from violent or accidental cause, not including suicide Participants definitely or possibly dying from TB related cause during the follow-up phase Participants requiring an extension of their treatment beyond that permitted by the protocol a restart or a change of treatment for any reason except reinfection or pregnancy Participants lost to follow up or withdrawn from the study before end of treatment |
52 weeks after start of therapy | |
Secondary | Time to Culture Negative Status | Culture conversion is a diagnostic criteria indicating the point at which samples taken from a patient infected with a tuberculosis can no longer produce tuberculosis cell cultures, that point is considered culture negativity | During treatment (17 or 26 weeks) |
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