Tuberculosis Clinical Trial
Official title:
A Phase 2 Open-Label Partially Randomized Trial to Evaluate the Efficacy, Safety and Tolerability of Combinations of Bedaquiline, Moxifloxacin, PA-824 and Pyrazinamide During 8 Weeks of Treatment in Adult Subjects With Newly Diagnosed Drug-Sensitive or Multi Drug-Resistant, Smear-Positive Pulmonary Tuberculosis.
The purpose of this study is to determine the mycobactericidal activity of combinations of bedaquiline (J), moxifloxacin (M), PA-824 (Pa) and pyrazinamide (Z) regimens during 8 weeks of treatment.
The trial design is a phase 2, multi-center, open-label, partially randomized clinical trial
in four parallel treatment groups. Subjects with drug-sensitive tuberculosis (DS-TB) will be
randomized to receive either J(loading dose/three times a week)PaZ; or J(200mg)PaZ; or HRZE.
Subjects with multi drug-resistant tuberculosis will receive J(200mg)MPaZ. The HRZE treatment
arm is included as a control for the drug-sensitive treatments and as a control for the
quantitative laboratory mycobacteriology testing.
A total of approximately 240 male and female, newly diagnosed subjects with drug-sensitive or
multi drug-resistant, smear positive pulmonary tuberculosis aged 18 to 75 years (inclusive)
will be included in the study. A total of 180 subjects with drug-sensitive tuberculosis (60
per treatment arm) will be randomized. Up to 60 subjects with multi-drug resistant
tuberculosis will be assigned.
All subjects will have up to a maximum of 9 days screening, receive 8 weeks of treatment, and
have follow-up visits at 2 and 12 weeks after study treatment completion or last dose of
investigational medicinal product in the case of early withdrawal. Subjects who withdraw from
the study after receiving < 14 days of investigational medicinal product, will only attend a
follow-up visit at 2 weeks after last dose of investigational medicinal product.
Upon treatment completion, the subjects with drug-sensitive tuberculosis will be provided
with sufficient doses of standard of care tuberculosis treatment, as appropriate, to cover
the time period from attending their last visit at the study clinic until their scheduled
visit at the TB clinic. All subjects with drug sensitive and multi-drug resistant
tuberculosis will be referred to the local community tuberculosis clinics for standard
anti-tuberculosis chemotherapy according to National Tuberculosis Guidelines.
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