NCT00277511

Levofloxacin, Chronic Bacterial Prostatitis

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 Chronic Bacterial Prostatitis (CBP)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (planned)
• Sponsor: Sanofi · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Prostatitis

Interventions

Type	Name	Description
DRUG	Levofloxacin

Timeline

• Start date: 2003-03-01
• First posted: 2006-01-16
• Last updated: 2007-10-12

Locations

1 site across 1 country: Germany