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A prospective, randomized, double dummy, double blind, multinational, multicenter trial comparing the safety and efficacy of sequential (intravenous/oral) moxifloxacin 400 mg once daily to intravenous...

Mise à jour : Il y a 4 ans
Référence : EUCTR2006-001599-18

A prospective, randomized, double dummy, double blind, multinational, multicenter trial comparing the safety and efficacy of sequential (intravenous/oral) moxifloxacin 400 mg once daily to intravenous piperacillin/tazobactam 4.0/0.5 g every 8 hours followed by oral amoxicillin/clavulanic acid tablets 875/125 mg every 12 hours for the treatment of subjects with complicated skin and skin structure infections (RELIEF Study)

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Extrait

The objective of this study is to compare the efficacy and safety of two sequential (IV/PO) treatment regimens for the treatment of adult subjects with cSSSIs: • Moxifloxacin, 400 mg IV every 24 hours followed by moxifloxacin 400 mg PO every 24 hours. • Piperacillin/tazobactam, 4.0/0.5 g administered IV three times daily followed by oral amoxicillin/clavulanic acid tablets, 875/125 mg twice daily. Treatment duration is aimed at minimum of 7 days and a maximum of 21 days. The primary efficacy criterion for the clinical trial is the clinical response assessed by an independent data review committee (DRC), 14-28 days after the completion of study drug therapy (Test-of-Cure visit [TOC]).

Critère d'inclusion

  • complicated skin and skin structure Infections

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