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Sponsors and Collaborators: |
Johns Hopkins University University of Texas Southwestern Medical Center |
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Information provided by: | Johns Hopkins University |
ClinicalTrials.gov Identifier: | NCT00596453 |
Ciprofloxacin hydrochloride has been approved by the Food and Drug Administration (FDA) for the treatment of mild to moderate infections, including prostate infections. It has been suggested that antibiotic treatment influences PSA levels due to the fact that an increase in PSA levels may be caused by inflammation or swelling of the prostate. Antibiotics are used to treat such inflammatory conditions. However, it has not been proven that antibiotics can be used to lower PSA. This research is being done to see if treatment with the antibiotic Ciprofloxacin hydrochloride affects the Prostate-Specific Antigen (PSA) blood test. This study may also help doctors in deciding which patients need a prostate biopsy.
Condition | Intervention |
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Prostate Infections |
Drug: Ciprofloxacin hydrochloride Drug: Placebo |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment |
Official Title: | Impact of Antibiotic Treatment on PSA Variability |
Estimated Enrollment: | 100 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Placebo: Placebo Comparator |
Drug: Placebo
Placebo twice a day for 14 days
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Ciprofloxacin hydrochloride: Experimental |
Drug: Ciprofloxacin hydrochloride
250 mg Ciprofloxacin hydrochloride twice a day for 14 days
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This study is directed towards men who have been referred to the Urology clinic at the Johns Hopkins Outpatient Center in Baltimore, MD. If a patient fits the eligibility criteria and signs a consent form, the patient will have his blood drawn for the first PSA measurement. The patient must return to the Johns Hopkins Outpatient Center one week later for a second PSA measurement. The patient will be randomized to receive treatment with placebo or Ciprofloxacin hydrochloride for 14 days. The patient must return to the Johns Hopkins Outpatient Center at the end of the treatment cycle for the third PSA measurement. The patient will return one week later for his biopsy and fourth PSA measurement.
Ages Eligible for Study: | 40 Years to 75 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Liz Humphreys | 410-502-3499 | ehumphr3@jhmi.edu |
Contact: Misop Han, M.D. | 410-502-7454 | mhan1@jhmi.edu |
United States, Maryland | |
Johns Hopkins Hospital Outpatient Center | |
Baltimore, Maryland, United States, 21287 |
Principal Investigator: | Misop Han, M.D., M.S. | Johns Hopkins Medical Institutions |
Responsible Party: | Johns Hopkins Medical Institutions ( Misop, Han, M.D. / Assistant Professor ) |
Study ID Numbers: | NA_00010549 |
Study First Received: | January 8, 2008 |
Last Updated: | January 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00596453 |
Health Authority: | United States: Institutional Review Board |
Prostate Specific Antigen (PSA) Elevated Prostate Specific Antigen (PSA) |
Ciprofloxacin |
Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Enzyme Inhibitors |
Infection Pharmacologic Actions Nucleic Acid Synthesis Inhibitors |