Clinical Trial: Levofloxacin, Chronic Bacterial Prostatitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Prospective, Multinational, Multicenter, Non-Comparative, Open Study With a 6 Months Follow-up Period to Demonstrate the Efficacy and Safety of Oral Levofloxacin 500 mg Once Daily in the Treatment of

Brief Summary:

Primary objective:

  • To investigate the microbiological efficacy, assessed as eradication rate based on microbiologically evaluable patients 1 month post treatment with oral Levofloxacin 500 mg in male adults with chronic bacterial prostatitis (CBP, category II)

Secondary objectives:

  • To investigate the microbiological efficacy, assessed as eradication rate based on microbiologically evaluable patients 6 months post treatment with oral Levofloxacin 500 mg in male adults with chronic bacterial prostatitis (CBP, category II).
  • To assess the clinical response rate based on resolution of signs and symptoms after 2 weeks of treatment; 5-12 days, 1 month, 3 months and 6 months post treatment with oral Levofloxacin 500 mg in male adults with chronic bacterial prostatitis (CBP, category II).
  • To assess the safety of Levofloxacin 500 mg on the basis of adverse events, standard clinical chemistry, hematology, urinalysis and vital signs in male adults with chronic bacterial prostatitis (CBP, category II).

Detailed Summary:
Sponsor: Sanofi

Current Primary Outcome: Primary efficacy data will be determined by eradication rate based on microbiologically evaluable subjects, evaluated for each pathogen and subject. [ Time Frame: determined at 1 month follow-up ]

Original Primary Outcome:

Current Secondary Outcome:

  • Secondary efficacy data will be determined by microbiological eradication rate [ Time Frame: at 6 months follow-up ]
  • clinical response rate based on resolution of signs and symptoms [ Time Frame: after 2 weeks of treatment and during follow-up period. ]


Original Secondary Outcome:

Information By: Sanofi

Dates:
Date Received: January 13, 2006
Date Started: March 2003
Date Completion:
Last Updated: October 11, 2007
Last Verified: October 2007