Antibiotic Prophylaxis for Transrectal Prostate Biopsy

Northwestern University

Status and phase

Completed

Phase 4

Conditions

Infection

Treatments

Drug: Ciprofloxacin

Drug: amikacin

Drug: gentamicin

Drug: imipenem

Drug: cefuroxime

Drug: ceftriaxone

Drug: aztreonam

Drug: trimethoprim-sulfamethoxazole

Study type

Interventional

Funder types

Other

Identifiers

NCT01659866

STU00059558

EAM-237 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

563 patients

Sex

Male

Ages

30 to 90 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

563 participants in 2 patient groups

Cipro-susceptible

Other 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

Treatment:

Drug: Ciprofloxacin

Cipro-resistant

Active Comparator group

Description:

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

Treatment:

Drug: gentamicin

Drug: ceftriaxone

Drug: amikacin

Drug: cefuroxime

Drug: imipenem

Drug: ceftriaxone

Drug: imipenem

Drug: trimethoprim-sulfamethoxazole

Drug: aztreonam

Drug: gentamicin

Drug: amikacin