Study Phase 3

A Multicenter, Double-blind, Randomized Study to Compare the Efficacy and Safety of Levofloxacin 750 mg Once Daily for Five Days Versus Ciprofloxacin Twice Daily for Ten Days in the Treatment of Complicated Urinary Tract Infection and Acute Pyelonephritis.

Trial Information

Generic NameLevofloxacinProduct NameLEVAQUIN®Therapeutic AreaUrinary Tract, Sexual Organs, and Pregnancy ConditionsEnrollment1109% Female60.9%% White68.5%
Product ClassQuinolones - 3rd gen.Sponsor Protocol NumberCAPSS-349Data PartnerJohnson & JohnsonCondition StudiedPyelonephritis, Urinary Tract InfectionsMean/Median Age (Years)54.2

Supporting Documentation

  • Collected Datasets Available
  • Data Definition Specification Available
  • Protocol with Amendments Available
  • Statistical Analysis Plan Available
  • Clinical Study Report Available

Approved Data Requests Associated with this Trial


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