Prostate CancerAbxNCT02247960
Antibiotic Prophylaxis for Urinary Catheter Removal After Radical Prostatectomy
A study testing Ciprofloxacin in people with Prostate Cancer and Urinary Tract Infection, run by University of Rochester at 1 site in United States.
Trial summary
The aim of this study is to determine whether antibiotics prophylaxis at the time of urinary catheter removal decreases the number of symptomatic urinary tract infections in patients after radical prostatectomy. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Urinary Tract Infection, Clostridium Difficile
- What is being tested?
- Ciprofloxacin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to May 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects will include patients undergoing radical prostatectomy for prostate cancer. Subjects will be randomized into control or treatment group.
Who cannot join
- Subjects with a history of adverse reaction to ciprofloxacin, or any other quinolone will be excluded. Subjects being treated with tizanidine or with a history of myasthenia gravis will be excluded. In addition, we will exclude patients with major immediate post-operative complications after prostatectomy including significant post-operative bleeding with known pelvic hematoma and known urine leak.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
The aim of this study is to determine whether antibiotics prophylaxis at the time of urinary catheter removal decreases the number of symptomatic urinary tract infections in patients after radical prostatectomy. In addition, the investigators aim to determine whether antibiotic prophylaxis is potentially harmful to patients (e.g. adverse reactions from antibiotic use, resistant bacteria in the urine, Clostridium difficile infections etc.). The investigators also aim to identify specific populations that may be at higher risk of developing urinary tract infections with urinary catheter use after radical prostatectomy.
- Being tested
- Ciprofloxacin
- Medical subject headings
- Prostatic Neoplasms, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CiprofloxacinDrug
Also called Cipro
| Study group | Role | What they receive |
|---|---|---|
| Ciprofloxacin | Active comparator | Antibiotic Receives: Drug: Ciprofloxacin |
| No Antibiotic | No intervention | No Antibiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With a Positive Urinary Tract Infection
After removal of the catheter, urine was tested for infection whenever symptoms were experienced by the participants from the time they enrolled to 12 months following their operation.
Measured: 12 months
Secondary outcomes (2)
Number of Participants Positive for Clostridium Difficile
Development of Clostridium difficile was measured in stool for clostridium difficile infection by enzyme immunoassay (EIA) and/or polymerase chain reaction (PCR).
Measured: 3 months
Number of Participants With Bacteria in Urine
Bacterial cultures were performed on urine and the presence of the following bacteria was determined: Acinetobacter, Coagulase-negative staphylococci, Diptherioids, Escherichia coli, Enterobacter, Enterococcus, Klebsiella pneumonia, and Lactoferrin. Participants who were positive for one or more of these were considered positive.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startJul 2014
- Primary completionMay 2016
- Study completionMay 2016
Why it stopped: Interim analysis determined that the study should be concluded for futility.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean Joseph, University of Rochester
- Investigators
- Jean V Joseph, M.D., Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02247960
- Sponsor's protocol ID
- RSRB#50607
- Acronym
- Abx
- Status last verified
- Mar 2017
- First submitted
- 29 Aug 2014
- Last updated
- 17 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Prophylaxis for Urinary Catheter Removal After Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT02247960
- Acronym / sponsor ID
- Abx / RSRB#50607
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim analysis determined that the study should be concluded for futility.
- Enrolment
- 175 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 25 Sep 2014 (estimated)
- Results
- Posted 15 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to determine whether antibiotics prophylaxis at the time of urinary catheter removal decreases the number of symptomatic urinary tract infections in patients after radical prostatectomy. In addition, the investigators aim to determine whether antibiotic prophylaxis is potentially harmful to patients (e.g. adverse reactions from antibiotic use, resistant bacteria in the urine, Clostridium difficile infections etc.). The investigators also aim to identify specific populations that may be at higher risk of developing urinary tract infections with urinary catheter use after radical prostatectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ciprofloxacin | Active comparator | Drug: CiprofloxacinAntibiotic |
| No Antibiotic | No intervention | –No Antibiotic |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects will include patients undergoing radical prostatectomy for prostate cancer. Subjects will be randomized into control or treatment group.
Key exclusion criteria (1 listed)
- Subjects with a history of adverse reaction to ciprofloxacin, or any other quinolone will be excluded. Subjects being treated with tizanidine or with a history of myasthenia gravis will be excluded. In addition, we will exclude patients with major immediate post-operative complications after prostatectomy including significant post-operative bleeding with known pelvic hematoma and known urine leak.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CiprofloxacinAlso: Cipro | Drug | Ciprofloxacin |
Primary outcome
Number of Participants With a Positive Urinary Tract Infection
Time frame: 12 months
After removal of the catheter, urine was tested for infection whenever symptoms were experienced by the participants from the time they enrolled to 12 months following their operation.
2 secondary outcomes
Number of Participants Positive for Clostridium Difficile
Time frame: 3 months
Number of Participants With Bacteria in Urine
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean V Joseph, M.D. principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ciprofloxacin in people with Prostate Cancer and Urinary Tract Infection, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With a Positive Urinary Tract Infection (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2017.