Tuberculosis Clinical Trial
Official title:
Pharmacokinetics and Safety of Moxifloxacin; a Dose Escalation in Patients With Tuberculosis
The main objective of this prospective clinical trial is to compare pharmacokinetics and safety and tolerability of a standard dose (400 mg) with an escalated dose (600 mg; 800 mg) of moxifloxacin (MFX). This clinical trial will provide important safety information on MFX in a higher dosage in TB patients.
Moxifloxacin (MFX) is a fluoroquinolone with a high in vitro and in vivo bactericidal
activity against Mycobacterium tuberculosis. A daily dose of 600-800 mg MFX should be
considered for optimal killing of the involved mycobacteria and suppression of drug
resistance, which is higher than the currently used dose of 400 mg once daily. In general,
safety data to support switching to the suggested higher dose are limited.
For this purpose, twenty tuberculosis patients will start on a standard dose of MFX 400 mg
once daily. After 8 days the dose will be increased to 600 mg once daily and on the 15th day
of treatment, the dose of MFX will be escalated to 800 mg. In patients who have been treated
with rifampicin (RIF) in the past three weeks prior to start of MFX treatment an additional
washout period of 3 weeks to reduce the rifampicin induced enzymatic activity will precede
the dose escalation.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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