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Levofloxacin, Chronic Bacterial Prostatitis

Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prostatitis

Intervention: Levofloxacin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Sanofi

Official(s) and/or principal investigator(s):
Katrin Roscher, Study Director, Affiliation: Sanofi

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).

Clinical Details

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 Chronic Bacterial Prostatitis (CBP)

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Primary efficacy data will be determined by eradication rate based on microbiologically evaluable subjects, evaluated for each pathogen and subject.

Secondary outcome:

Secondary efficacy data will be determined by microbiological eradication rate

clinical response rate based on resolution of signs and symptoms

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

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

- 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 (a

clinical diagnosis of prostatitis having been made for at least one previous episode which episode having lasted four weeks or two or more other episodes during 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 subject

has been receiving must continue throughout the study at the same dose or be discontinued 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 including

transurethral prostatectomy within 6 months of enrollment, the presence of a permanent transurethral catheter or a history of cystostomy or nephrostomy

- Taking medication that may effect bladder or prostate function (e. g. hormone therapy

anticholinergics or alpha-blocker)

- Patients not receiving saw palmetto at the time of study entry should not start

treatment with saw palmetto within 10 weeks of study entry

- Known prostatic carcinoma

- The presence of another infection requiring therapy with an antibacterial other than

the study drug

- Greater than 24 hours of potentially effective therapy within seven days prior to

study when there is documented evidence of a resistant organism or clinical failure after five or more days of previous antibacterial therapy

- History of hypersensitivity to the investigational product or to drugs with similar

chemical 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 by

the clinical study protocol.

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

- Clinically relevant cardiovascular, hepatic, neurologic, endocrine or other major

systemic disease making implementation of the protocol or interpretation of the study results 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 ┬Ámol/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 or

undergoing hemodialysis or peritoneal dialysis (creatinine clearance may be estimated by formula or nomogram)

- Underweight (40 kg or less)

Locations and Contacts

Sanofi-Aventis, Berlin, Germany
Additional Information

Starting date: March 2003
Last updated: October 11, 2007

Page last updated: August 23, 2015

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