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NCT00596453 · ClinicalTrials.gov registry record · Phase 4
Impact of Antibiotic Treatment on Prostate-Specific Antigen (PSA) Variability
A Phase 4 study, sponsored by Johns Hopkins University.
- Terminated
- Registry status
- Phase 4
- Development phase
- 31
- Enrollment target
NCT00596453: Clinical Trial Phase 4 study, sponsored by Johns Hopkins University.
NCT00596453 is a Phase 4 study that was terminated before completion, run by Johns Hopkins University. The registered enrollment target is 31 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00596453, a Phase 4 study, was terminated before completion, sponsored by Johns Hopkins University.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 31 participants
- Enrollment target
Study Summary
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.
Primary Outcome
We took 4 Prostate Specific Antigen (PSA, ng/mL) measurements per participant. The first PSA test was performed at enrollment. The second PSA test was performed 7 days (+/-3 days) later. Then the participants took the Placebo or Cipro for 14 days. The participants returned for their 3rd PSA test upon completion of the Placebo or Cipro. The final PSA test was performed 7 days (+/-3 days) after the 3rd test. We planned to compare the differences between the first two PSA tests and the last two PS
Interventions
- DRUG Placebo
- DRUG Ciprofloxacin hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2008-01 |
| Est. Completion | 2011-06 |
| Phase | Phase 4 |
Why NCT00596453 stopped before completion
NCT00596453 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00596453 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00596453 about?
NCT00596453 is a clinical study titled "Impact of Antibiotic Treatment on Prostate-Specific Antigen (PSA) Variability". 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 ...
What is the current status of trial NCT00596453?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 31 participants. The study started on 2008-01. Estimated completion is 2011-06.
What interventions are being tested in trial NCT00596453?
The interventions under investigation include: Placebo (DRUG), Ciprofloxacin hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00596453?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00596453's enrollment target sits among peer trials
31 1544th of 2000 higher than 449 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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