In this phase II clinical trial, the pharmacokinetics, safety and (short-term) efficacy of higher than standard doses rifampicin will be studied during the intensive phase of tuberculosis (TB) treatment. Patients enrolled in this study will either get the standard TB regimen (including 600 mg rifampicin; first study arm), or 900 mg rifampicin plus isoniazid, ethambutol and pyrazinamide in standard dosages (second study arm), or 1200 mg rifampicin plus the other drugs in standard dosages (third study arm). All patients will get the standard TB regimen during the continuation phase of treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
150
Rifampicin 900 mg (study arm 2), and rifampicin 1200 mg (study arm 3)
Kibong'oto National Tuberculosis Hospital
Sanya Juu, Kilimanjaro, Tanzania
Pharmacokinetic parameters of rifampicin, desacetylrifampicin, isoniazid, pyrazinamide, ethambutol
Time frame: Steady state, week 6
Occurrence of adverse events
Time frame: baseline, week 1, 2, 4, 6, 8, 10, 12
Bacteriological response of Mycobacterium tuberculosis
Time frame: Almost daily during first 8 weeks
Compare accuracy of surrogate markers (SSCC, mRNA, cytokines) with standard two-month sputum conversion marker
Time frame: Almost daily during first 8 weeks
Documenting the occurrence of mixed Mycobacterium tuberculosis strain infections
Time frame: Almost daily during first 8 weeks
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