Multi-drug Resistant Tuberculosis Clinical Trial
Official title:
Pharmacokinetics of Levofloxacin in MDR-TB Patients
The emergence and spread of multi-drug resistant and extensively-drug resistant strains of
Mycobacterium tuberculosis (MDR/XDR-TB) have posed a great threat to global TB control and
elimination, limiting treatment success rate at worrisome 50% for MDR-TB. Among various
factors contributing to the development of drug resistance, low drug exposure is well
recognized. To overcome this, either new drugs have to be developed or the dose of currently
used therapy be optimized, or both. Fluoroquinolones (levofloxacin and moxifloxacin) and
aminoglycosides are important drugs in the MDR-TB treatment regimen. Development of acquired
drug resistance to these drugs could complicate and narrow down the available options, and
further exacerbate to pre-XDR and XDR-TB.
Objective:
The main objective of this prospective clinical study is to understand the pharmacokinetics
of levofloxacin in MDR-TB patients, receiving standard dosage (750-1250mg) based on the body
weight and correlate drug exposure, with treatment outcomes.
Study design:
A prospective pharmacokinetic study
Study population: 20 MDR-TB patients
Intervention: Patients receive once daily oral dosing of levofloxacin (750-1250mg) based on
the body weight, under MDR-TB treatment regimen of Nepal.
Main study parameters/end points:
The pharmacokinetic parameters(Vd, CL, AUC etc.) of levofloxacin are the primary end points
of the study. The Cmax/MIC and AUC0-24h/MIC ratios are the best predictive parameters for
efficacy of levofloxacin treatment and will be estimated. Pharmacokinetics will be evaluated
in plasma and in oral fluid
n/a
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