Levofloxacin, Chronic Bacterial Prostatitis

Inclusion Criteria: Subjects meeting all of the following criteria will be considered for enrollment into thestudy:

• A clinical diagnosis of chronic prostatitis as evidenced by the following criteria:

• clinical signs and symptoms of prostatitis and

• a history of chronic prostatitis as defined as: symptomatic prostatitis (aclinical diagnosis of prostatitis having been made for at least one previousepisode which episode having lasted four weeks or two or more other episodesduring the previous twelve months) and leucocyturia greater/equal 10 WBC/HPF x 400

• Laboratory evidence of prostatitis

• Candidate is appropriate for oral therapy.

• OTC medications for chronic prostatitis (other than antibiotics), which the subjecthas been receiving must continue throughout the study at the same dose or bediscontinued prior to study entry.

Exclusion Criteria: Subjects presenting with any of the following will not be included in the study:

• Need for parenteral therapy for the treatment of chronic bacterial prostatitis (CBP,Category II)

• Subjects with pathogen known or suspected to be resistant to the study drug

• Requirement for a second systemic antibacterial regimen

• Any condition which may interfere with the evaluation of the study drug includingtransurethral prostatectomy within 6 months of enrollment, the presence of a permanenttransurethral catheter or a history of cystostomy or nephrostomy

• Taking medication that may effect bladder or prostate function (e.g. hormone therapyanticholinergics or alpha-blocker)

• Patients not receiving saw palmetto at the time of study entry should not starttreatment with saw palmetto within 10 weeks of study entry

• Known prostatic carcinoma

• The presence of another infection requiring therapy with an antibacterial other thanthe study drug

• Greater than 24 hours of potentially effective therapy within seven days prior tostudy when there is documented evidence of a resistant organism or clinical failureafter five or more days of previous antibacterial therapy

• History of hypersensitivity to the investigational product or to drugs with similarchemical structures

• History of tendonitis or tendon rupture

• Treatment with other quinolones in the last 14 days before study entry

• Likelihood of requiring treatment during the study period with drugs not permitted bythe clinical study protocol.

• Treatment with any investigational product in the last 30 days before study entry

• Clinically relevant cardiovascular, hepatic, neurologic, endocrine or other majorsystemic disease making implementation of the protocol or interpretation of the studyresults difficult

• History of drug or alcohol abuse

• Impaired hepatic function, as shown by:

• AST (SGOT) greater/equal 3 times the upper limit of the reference range

• ALT (SGPT) greater/equal 3 times the upper limit of the reference range

• bilirubin greater 51 µmol/l, i.e., greater 3 mg/dl (except of Gilbert disease)

• hepatic encephalopathy

• Impaired renal function, as shown by either creatinine clearance smaller 50 ml/min orundergoing hemodialysis or peritoneal dialysis (creatinine clearance may be estimatedby formula or nomogram)

• Underweight (40 kg or less)