Antibiotic Prophylaxis for Transrectal Prostate Biopsy
Study Details
Study Description
Brief 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. 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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 4 |
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
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Other: Cipro-susceptible Patients with ciprofloxacin-susceptible bacteria on their rectal swab cultures will receive ciprofloxacin, the standard of care, as prophylaxis for their prostate biopsy |
Drug: Ciprofloxacin
500 mg orally 2 hours before prostate biopsy
|
Active Comparator: Cipro-resistant 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 |
Drug: trimethoprim-sulfamethoxazole
1 double strength tablet orally 2 hours before the procedure and again 12 hours later
Drug: cefuroxime
500 mg orally 2 hours before the procedure then again 12 hours later
Drug: ceftriaxone
500 mg intramuscularly 2 hours before the procedure
Drug: gentamicin
2 mg/kg intramuscularly 2 hours before the procedure
Drug: amikacin
5 mg/kg intramuscularly 2 hours before the procedure
Drug: aztreonam
500 mg intramuscularly 2 hours before the procedure
Drug: imipenem
500 mg intramuscularly 2 hours before the procedure
Drug: ceftriaxone
2000 mg intravenously 1 hour before the procedure
Drug: gentamicin
2 mg/kg intravenously 1 hour before the procedure
Drug: amikacin
5 mg/kg intravenously 1 hour before the procedure
Drug: aztreonam
2000 mg intravenously 1 hour before the procedure
Drug: imipenem
1000 mg intravenously 1 hour before the procedure
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Post-biopsy Infection. [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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.
Exclusion Criteria:
-
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Northwestern University Department of Urology | Chicago | Illinois | United States | 60611 |
Sponsors and Collaborators
- Northwestern University
Investigators
- Principal Investigator: Anthony J Schaeffer, MD, Northwestern University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STU00059558
- EAM-237
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail | 563 patients consented and of these, 53 were excluded as follows: 16 patients had issues with informed consent, 20 received antimicrobials off protocol, 16 did not undergo TRUSP and 1 was lost to follow up. Thus 510 patients underwent swabs; 430 had CS isolates while 80 had CR isolates. All 510 patients completed the study. |
Arm/Group Title | Cipro-susceptible | Cipro-resistant |
---|---|---|
Arm/Group Description | Patients with ciprofloxacin-susceptible bacteria on their rectal swab cultures will receive ciprofloxacin, the standard of care, as prophylaxis for their prostate biopsy Ciprofloxacin: 500 mg orally 2 hours before prostate biopsy | 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 |
Period Title: Overall Study | ||
STARTED | 430 | 80 |
COMPLETED | 430 | 80 |
NOT COMPLETED | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Cipro-susceptible | Cipro-resistant | Total |
---|---|---|---|
Arm/Group Description | Patients with ciprofloxacin-susceptible bacteria on their rectal swab cultures will receive ciprofloxacin, the standard of care, as prophylaxis for their prostate biopsy Ciprofloxacin: 500 mg orally 2 hours before prostate biopsy | 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 | Total of all reporting groups |
Overall Participants | 430 | 80 | 510 |
Age (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
62.7
(9.1)
|
61.6
(7.6)
|
62.4
(8.8)
|
Sex: Female, Male (Count of Participants) | |||
Female |
0
0%
|
0
0%
|
0
0%
|
Male |
430
100%
|
80
100%
|
510
100%
|
Region of Enrollment (participants) [Number] | |||
United States |
430
100%
|
80
100%
|
510
100%
|
Outcome Measures
Title | Number of Participants With Post-biopsy Infection. |
---|---|
Description | 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. |
Time Frame | 30 days post-biopsy |
Outcome Measure Data
Analysis Population Description |
---|
Of the 563 patients who signed consent, 53 were excluded; thus, 510 patients participated in the study. Of these 510, 430 harbored ciprofloxacin-susceptible flora and 80 harbored ciprofloxacin-resistant flora. |
Arm/Group Title | Cipro-susceptible | Cipro-resistant |
---|---|---|
Arm/Group Description | Patients with ciprofloxacin-susceptible bacteria on their rectal swab cultures will receive ciprofloxacin, the standard of care, as prophylaxis for their prostate biopsy Ciprofloxacin: 500 mg orally 2 hours before prostate biopsy | 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 |
Measure Participants | 430 | 80 |
Number [participants] |
6
1.4%
|
3
3.8%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Cipro-susceptible, Cipro-resistant |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.05 |
Comments | ||
Method | Fisher Exact | |
Comments |
Adverse Events
Time Frame | 30 days | |||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | Cipro-susceptible | Cipro-resistant | ||
Arm/Group Description | Patients with ciprofloxacin-susceptible bacteria on their rectal swab cultures will receive ciprofloxacin, the standard of care, as prophylaxis for their prostate biopsy Ciprofloxacin: 500 mg orally 2 hours before prostate biopsy | 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 | ||
All Cause Mortality |
||||
Cipro-susceptible | Cipro-resistant | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/430 (0%) | 0/80 (0%) | ||
Serious Adverse Events |
||||
Cipro-susceptible | Cipro-resistant | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/430 (0%) | 0/80 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
Cipro-susceptible | Cipro-resistant | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/430 (0%) | 0/80 (0%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Dr. Anthony Schaeffer |
---|---|
Organization | Northwestern University |
Phone | 312-908-1615 |
ajschaeffer@northwestern.edu |
- STU00059558
- EAM-237