Tuberculosis, Pulmonary Clinical Trial
Official title:
Optimization of the TB Treatment Regimen Cascade
- Hypothesis: Double dose rifampicin together with earlier monitoring of sputum conversion
using vital staining reduces unfavorable outcome of Cat. 1 first-line TB treatment without
excess serious toxicity, and allows early switch to specific treatment of MDR-TB without
using Cat. 2 retreatment regimen
- General study design: This open label, randomised clinical trial is intended as a pilot
study on the efficacy and safety of high-dose rifampicin and feasibility and added value of
auramine and/or FDA vital staining sputum smear after 2 weeks of intensive treatment phase.
If this proof-of-concept study provides substantial indication of benefit without indication
of excess toxicity, the data from the study will be used to design a larger scale,
cluster-randomized study. The aim of this cluster randomised study would be to provide
definite proof of the benefit of the intervention on adverse treatment outcomes and lack of
excess toxicity associated with high dose rifampicin. In addition, the cluster-randomized
study would provide a more precise assessment of the suppression and prevention of (acquired)
resistance endpoints.
An interim analysis is thus planned at the time the last recruited patient finishes
treatment, i.e. about 9 months after the end of recruitment. It will focus on assessment of
drug toxicity versus suggested benefits of the intervention. This analysis will be primarily
performed for the go/no-go decision and design considerations for the cluster-randomized
trial. The decision on proceeding to the cluster randomized study will be based on the
absence of excess toxicity, a trend toward a reduction of unfavourable outcomes (excluding
relapse), and possible favourable effects on initially present low-resistance mutations /
mutations acquired during treatment. It will also allow to adapt the design of the larger
study particularly regarding the algorithm for resistance screening, and whether or not
treatment shortening could be justified with rapid initial conversion.
n/a
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