Study Phase 3

A Multicenter, Randomized, Open-Label, Comparative Study to Compare the Efficacy and Safety of Levofloxacin and Standard of Care Therapy in the Treatment of Children With Community-Acquired Pneumonia in the Hospitalized or Outpatient Setting

Trial Information

Generic NameLevofloxacinProduct NameLEVAQUIN®Therapeutic AreaRespiratory Tract (Lung and Bronchial) DiseasesEnrollment738% Female50%% White51%
Product ClassQuinolones - 3rd gen.Sponsor Protocol NumberCR002392/LOFBIV-PCAP-003Data PartnerJohnson & JohnsonCondition StudiedPneumoniaMean/Median Age (Years)5.5

Supporting Documentation

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

Disclaimer

Clinical study data provided through this site do not replace the official labeling of a given drug product, which presents benefits and risks of the product for approved use(s). Before prescribing any product, health care professionals should consult the current prescribing information approved in their country. Patients seeking information may consult with their health care professional about the product, for which health authority approved written patient information may be available.