InfectionPhase 4NCT01659866
Antibiotic Prophylaxis for Transrectal Prostate Biopsy
A Phase 4 study testing Ciprofloxacin, trimethoprim-sulfamethoxazole and cefuroxime in people with Infection, run by Northwestern University at 1 site in United States.
Trial summary
This study is being conducted in men scheduled to undergo transrectal ultrasound-guided prostate biopsy (TRUSP). Traditionally prior to prostate biopsy, an antibiotic, ciprofloxacin, has been given to men to prevent biopsy-related infections. Read more about this study
- Who is it for?
- Ages 30 to 90 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Infection
- What is being tested?
- Ciprofloxacin, trimethoprim-sulfamethoxazole and cefuroxime
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 563 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Aug 2016
- Phase
- Phase 4
- 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 30 to 90 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ability and willingness to provide written informed consent.
- All individuals who will undergo TRUSP as part of their standard of care are eligible for study.
Who cannot join
- Men under 30 years of age
- Individuals whose rectal swab indicates that they harbor CS-GNB who cannot receive ciprofloxacin as pre-procedure prophylaxis for any reason
- Individuals whose rectal swab indicates that they harbor CR-GNB who cannot abide by the antimicrobial prophylaxis guidelines outlined in the study protocol for any reason
- Individuals who do not wish to complete the pre-procedure risk factor questionnaire or the two post-procedure phone questionnaires to assess for infectious complications
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Department of Urology
Chicago, Illinois, 60611
About this study
Official title: Evaluation of Directed Antimicrobial Prophylaxis for Transrectal Ultrasound Guided Prostate Biopsy (TRUSP)
This study is being conducted in men scheduled to undergo transrectal ultrasound-guided prostate biopsy (TRUSP). Traditionally prior to prostate biopsy, an antibiotic, ciprofloxacin, has been given to men to prevent biopsy-related infections. In recent years as ciprofloxacin resistance has increased in the community, more and more men are becoming infected with ciprofloxacin-resistant bacteria after prostate biopsy. This study is being done to determine if obtaining rectal swab cultures and choosing antibiotics based on these culture results will result in fewer infectious complications than giving all men ciprofloxacin.
The investigators will compare 2 groups: men whose rectal swabs do not show ciprofloxacin-resistant bacteria will receive ciprofloxacin prior to biopsy, and men whose swabs do show ciprofloxacin-resistant bacteria will receive alternative antibiotics based on their culture results. Our hypothesis is that these 2 groups will have equal numbers of post-biopsy infectious complications and both groups will have fewer infectious complications than a historical group who received empiric ciprofloxacin without the benefit of rectal swab culture results.
Read the detailed description
This study is a prospective, nonrandomized trial evaluating the efficacy of directed antimicrobial prophylaxis prior to transrectal ultrasound-guided prostate biopsy (TRUSP) compared with ciprofloxacin prophylaxis, the current standard of care. Northwestern University will be the lead site. After signing informed consent, study participants will complete a pre-biopsy questionnaire to record demographics and assess for known risk factors for infection and will have a rectal swab obtained. Patients whose swabs indicate colonization with ciprofloxacin-susceptible gram-negative bacteria (CS-GNB) will receive ciprofloxacin as pre-procedure prophylaxis and those whose swabs indicate colonization with ciprofloxacin-resistant gram-negative bacteria (CR-GNB) will receive pre-procedure antimicrobial prophylaxis based on study protocol.
All patients will be contacted by phone twice after their biopsies, at approximately 7 and 30 days, to detail post-procedure infectious complications including fever, urinary tract infection, bacteremia and sepsis. Subjects who experience infections will have additional information regarding the infectious complications and cost of therapy abstracted from their medical record. The TRUSP results will also be recorded. Bacterial isolates from the rectal swabs will be archived.
- Conditions
- Infection
- Being tested
- Ciprofloxacin, trimethoprim-sulfamethoxazole, cefuroxime, ceftriaxone, gentamicin
- Keywords
- Infection, Antibiotic resistance, Prostate biopsy
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CiprofloxacinDrug
500 mg orally 2 hours before prostate biopsy
trimethoprim-sulfamethoxazoleDrug
1 double strength tablet orally 2 hours before the procedure and again 12 hours later
cefuroximeDrug
500 mg orally 2 hours before the procedure then again 12 hours later
ceftriaxoneDrug
500 mg intramuscularly 2 hours before the procedure
gentamicinDrug
2 mg/kg intramuscularly 2 hours before the procedure
amikacinDrug
5 mg/kg intramuscularly 2 hours before the procedure
aztreonamDrug
500 mg intramuscularly 2 hours before the procedure
imipenemDrug
500 mg intramuscularly 2 hours before the procedure
ceftriaxoneDrug
2000 mg intravenously 1 hour before the procedure
gentamicinDrug
2 mg/kg intravenously 1 hour before the procedure
amikacinDrug
5 mg/kg intravenously 1 hour before the procedure
aztreonamDrug
2000 mg intravenously 1 hour before the procedure
imipenemDrug
1000 mg intravenously 1 hour before the procedure
| Study group | Role | What they receive |
|---|---|---|
| Cipro-susceptible | Other | Patients with ciprofloxacin-susceptible bacteria on their rectal swab cultures will receive ciprofloxacin, the standard of care, as prophylaxis for their prostate biopsy Receives: Drug: Ciprofloxacin |
| Cipro-resistant | Active comparator | Patients with ciprofloxacin-resistant bacteria on their rectal swab will receive one of the following drugs:
* trimethoprim-sulfamethoxazole 1 double strength tablet orally 2 hours before the procedure and again 12 hours later
* cefuroxime 500 mg orally 2 hours before the procedure then again 12 hours later
* ceftriaxone 500 mg intramuscularly 2 hours before the procedure
* gentamicin 2mg/kg intramuscularly 2 hours before the procedure
* amikacin 5 mg/kg intramuscularly 2 hours before the procedure
* aztreonam 500 mg intramuscularly 2 hours before the procedure
* imipenem 500 mg intramuscularly 2 hours before the procedure
* ceftriaxone 2000 mg intravenously 1 hour before the procedure
* gentamicin 2 mg/kg intravenously 1 hour before the procedure
* amikacin 5mg/kg intravenously 1 hour before the procedure
* aztreonam 2000 mg intravenously 1 hour before the procedure
* imipenem 1000 mg intravenously 1 hour before the procedure Receives: Drug: trimethoprim-sulfamethoxazole; Drug: cefuroxime; Drug: ceftriaxone; Drug: gentamicin; Drug: amikacin; Drug: aztreonam; Drug: imipenem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Post-biopsy Infection.
To measure and compare the rates of infection following TRUSP in subjects with and without CR-GNB. This measure is number of participants with post-biopsy infection.
Measured: 30 days post-biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2015
- Study completionAug 2016
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfectionStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 563 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anthony Schaeffer, Northwestern University
- Investigators
- Anthony J Schaeffer, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01659866
- Sponsor's protocol ID
- STU00059558
- Other IDs
- EAM-237
- Status last verified
- Sep 2016
- First submitted
- 9 Jul 2012
- Last updated
- 25 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Zembower TR, Maxwell KM, Nadler RB, Cashy J, Scheetz MH, Qi C, Schaeffer AJ. Evaluation of targeted antimicrobial prophylaxis for transrectal ultrasound guided prostate biopsy: a prospective cohort trial. BMC Infect Dis. 2017 Jun 7;17(1):401. doi: 10.1186/s12879-017-2470-1.
PubMed 28592230
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Directed Antimicrobial Prophylaxis for Transrectal Ultrasound Guided Prostate Biopsy (TRUSP)
- ClinicalTrials.gov ID
- NCT01659866
- Acronym / sponsor ID
- STU00059558
- Conditions
- Infection
- Keywords
- Infection, Antibiotic resistance, Prostate biopsy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 563 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 8 Aug 2012 (estimated)
- Results
- Posted 25 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being conducted in men scheduled to undergo transrectal ultrasound-guided prostate biopsy (TRUSP). Traditionally prior to prostate biopsy, an antibiotic, ciprofloxacin, has been given to men to prevent biopsy-related infections. In recent years as ciprofloxacin resistance has increased in the community, more and more men are becoming infected with ciprofloxacin-resistant bacteria after prostate biopsy. This study is being done to determine if obtaining rectal swab cultures and choosing antibiotics based on these culture results will result in fewer infectious complications than giving all men ciprofloxacin.
The investigators will compare 2 groups: men whose rectal swabs do not show ciprofloxacin-resistant bacteria will receive ciprofloxacin prior to biopsy, and men whose swabs do show ciprofloxacin-resistant bacteria will receive alternative antibiotics based on their culture results. Our hypothesis is that these 2 groups will have equal numbers of post-biopsy infectious complications and both groups will have fewer infectious complications than a historical group who received empiric ciprofloxacin without the benefit of rectal swab culture results.
Detailed description
This study is a prospective, nonrandomized trial evaluating the efficacy of directed antimicrobial prophylaxis prior to transrectal ultrasound-guided prostate biopsy (TRUSP) compared with ciprofloxacin prophylaxis, the current standard of care. Northwestern University will be the lead site. After signing informed consent, study participants will complete a pre-biopsy questionnaire to record demographics and assess for known risk factors for infection and will have a rectal swab obtained. Patients whose swabs indicate colonization with ciprofloxacin-susceptible gram-negative bacteria (CS-GNB) will receive ciprofloxacin as pre-procedure prophylaxis and those whose swabs indicate colonization with ciprofloxacin-resistant gram-negative bacteria (CR-GNB) will receive pre-procedure antimicrobial prophylaxis based on study protocol.
All patients will be contacted by phone twice after their biopsies, at approximately 7 and 30 days, to detail post-procedure infectious complications including fever, urinary tract infection, bacteremia and sepsis. Subjects who experience infections will have additional information regarding the infectious complications and cost of therapy abstracted from their medical record. The TRUSP results will also be recorded. Bacterial isolates from the rectal swabs will be archived.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cipro-susceptible | Other | Drug: CiprofloxacinPatients with ciprofloxacin-susceptible bacteria on their rectal swab cultures will receive ciprofloxacin, the standard of care, as prophylaxis for their prostate biopsy |
| Cipro-resistant | Active comparator | Drug: trimethoprim-sulfamethoxazole, Drug: cefuroxime, Drug: ceftriaxone, Drug: gentamicin, Drug: amikacin, Drug: aztreonam, Drug: imipenemPatients with ciprofloxacin-resistant bacteria on their rectal swab will receive one of the following drugs: * trimethoprim-sulfamethoxazole 1 double strength tablet orally 2 hours before the procedure and again 12 hours later * cefuroxime 500 mg orally 2 hours before the procedure then again 12 hours later * ceftriaxone 500 mg intramuscularly 2 hours before the procedure * gentamicin 2mg/kg intramuscularly 2 hours before the procedure * amikacin 5 mg/kg intramuscularly 2 hours before the procedure * aztreonam 500 mg intramuscularly 2 hours before the procedure * imipenem 500 mg intramuscularly 2 hours before the procedure * ceftriaxone 2000 mg intravenously 1 hour before the procedure * gentamicin 2 mg/kg intravenously 1 hour before the procedure * amikacin 5mg/kg intravenously 1 hour before the procedure * aztreonam 2000 mg intravenously 1 hour before the procedure * imipenem 1000 mg intravenously 1 hour before the procedure |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ability and willingness to provide written informed consent.
- All individuals who will undergo TRUSP as part of their standard of care are eligible for study.
Key exclusion criteria (4 listed)
- Men under 30 years of age
- Individuals whose rectal swab indicates that they harbor CS-GNB who cannot receive ciprofloxacin as pre-procedure prophylaxis for any reason
- Individuals whose rectal swab indicates that they harbor CR-GNB who cannot abide by the antimicrobial prophylaxis guidelines outlined in the study protocol for any reason
- Individuals who do not wish to complete the pre-procedure risk factor questionnaire or the two post-procedure phone questionnaires to assess for infectious complications
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 |
|---|---|---|
| Ciprofloxacin500 mg orally 2 hours before prostate biopsy | Drug | Cipro-susceptible |
| trimethoprim-sulfamethoxazole1 double strength tablet orally 2 hours before the procedure and again 12 hours later | Drug | Cipro-resistant |
| cefuroxime500 mg orally 2 hours before the procedure then again 12 hours later | Drug | Cipro-resistant |
| ceftriaxone500 mg intramuscularly 2 hours before the procedure | Drug | Cipro-resistant |
| gentamicin2 mg/kg intramuscularly 2 hours before the procedure | Drug | Cipro-resistant |
| amikacin5 mg/kg intramuscularly 2 hours before the procedure | Drug | Cipro-resistant |
| aztreonam500 mg intramuscularly 2 hours before the procedure | Drug | Cipro-resistant |
| imipenem500 mg intramuscularly 2 hours before the procedure | Drug | Cipro-resistant |
| ceftriaxone2000 mg intravenously 1 hour before the procedure | Drug | Cipro-resistant |
| gentamicin2 mg/kg intravenously 1 hour before the procedure | Drug | Cipro-resistant |
| amikacin5 mg/kg intravenously 1 hour before the procedure | Drug | Cipro-resistant |
| aztreonam2000 mg intravenously 1 hour before the procedure | Drug | Cipro-resistant |
| imipenem1000 mg intravenously 1 hour before the procedure | Drug | Cipro-resistant |
Primary outcome
Number of Participants With Post-biopsy Infection.
Time frame: 30 days post-biopsy
To measure and compare the rates of infection following TRUSP in subjects with and without CR-GNB. This measure is number of participants with post-biopsy infection.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28592230Zembower TR, Maxwell KM, Nadler RB, Cashy J, Scheetz MH, Qi C, Schaeffer AJ. Evaluation of targeted antimicrobial prophylaxis for transrectal ultrasound guided prostate biopsy: a prospective cohort trial. BMC Infect Dis. 2017 Jun 7;17(1):401. doi: 10.1186/s12879-017-2470-1.
- Individual participant dataSharing planned: Yes
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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.
Anthony J Schaeffer, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ciprofloxacin, trimethoprim-sulfamethoxazole and cefuroxime in people with Infection, run by Northwestern University 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 25 Jun 2019. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jun 2019). 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 Post-biopsy Infection. (time frame: 30 days post-biopsy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01659866, which also lists 1 linked publication.
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 25 Jun 2019.