Infection
Conditions
Keywords
Infection, Antibiotic resistance, Prostate biopsy
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.
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.
Interventions
DRUGCiprofloxacin
500 mg orally 2 hours before prostate biopsy
DRUGtrimethoprim-sulfamethoxazole
1 double strength tablet orally 2 hours before the procedure and again 12 hours later
DRUGcefuroxime
500 mg orally 2 hours before the procedure then again 12 hours later
DRUGceftriaxone
500 mg intramuscularly 2 hours before the procedure
DRUGgentamicin
2 mg/kg intramuscularly 2 hours before the procedure
DRUGamikacin
5 mg/kg intramuscularly 2 hours before the procedure
DRUGaztreonam
500 mg intramuscularly 2 hours before the procedure
DRUGimipenem
500 mg intramuscularly 2 hours before the procedure
Sponsors
Northwestern University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
30 Years to 90 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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
Ciprofloxacin: 500 mg orally 2 hours before prostate biopsy | 430 |
| 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 | 80 |
| Total | 510 |
Baseline characteristics
| Characteristic | Cipro-susceptible | Cipro-resistant | Total |
|---|---|---|---|
| Age, Continuous | 62.7 years STANDARD_DEVIATION 9.1 | 61.6 years STANDARD_DEVIATION 7.6 | 62.4 years STANDARD_DEVIATION 8.8 |
| Region of Enrollment United States | 430 participants | 80 participants | 510 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 430 Participants | 80 Participants | 510 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 430 | 0 / 80 |
| other Total, other adverse events | 0 / 430 | 0 / 80 |
| serious Total, serious adverse events | 0 / 430 | 0 / 80 |
Outcome results
Primary
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.
Time frame: 30 days post-biopsy
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Cipro-susceptible | Number of Participants With Post-biopsy Infection. | 6 participants |
| Cipro-resistant | Number of Participants With Post-biopsy Infection. | 3 participants |
p-value: <0.05Fisher Exact