Status:
COMPLETED
Trial to Evaluate the Efficacy, Safety and Tolerability of BPaMZ in Drug-Sensitive (DS-TB) Adult Patients and Drug-Resistant (DR-TB) Adult Patients
Lead Sponsor:
Global Alliance for TB Drug Development
Conditions:
Tuberculosis, Pulmonary
Tuberculosis, Multidrug-Resistant
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
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 S...
Detailed Description
Phase 2c multi-center, open-label, partially randomized clinical trial in DS-TB and DR-TB participants. All participants in the below arms will have follow-up for a period of 104 weeks (24 months) fr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 30 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 10 2022
Estimated Enrollment :
455 Patients enrolled
Trial Details
Trial ID
NCT03338621
Start Date
July 30 2018
End Date
June 10 2022
Last Update
March 7 2024
Active Locations (26)
Enter a location and click search to find clinical trials sorted by distance.
1
Evandro Chagas
Rio de Janeiro, Brazil
2
FIOCRUZ
Rio de Janeiro, Brazil
3
National Center for Tuberculosis and Lung Diseases
Tbilisi, Georgia, 0101
4
Institut Perubatan Respiratori
Kuala Lumpur, Malaysia