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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Sanofi-Aventis
Berlin, Germany
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
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.
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