Antibiotic Prophylaxis for Transrectal Prostate Biopsy
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 30 - 90 |
| Updated: | 10/14/2017 |
| Start Date: | August 2012 |
| End Date: | August 2016 |
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.
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.
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.
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.
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
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