Antibiotic Prophylaxis for Transrectal Prostate Biopsy

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

563 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2016-08-31

Brief Summary

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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.

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Detailed Description

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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

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Infection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type OTHER

Ciprofloxacin

Intervention Type DRUG

500 mg orally 2 hours before prostate biopsy

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

Group Type ACTIVE_COMPARATOR

trimethoprim-sulfamethoxazole

Intervention Type DRUG

1 double strength tablet orally 2 hours before the procedure and again 12 hours later

cefuroxime

Intervention Type DRUG

500 mg orally 2 hours before the procedure then again 12 hours later

ceftriaxone

Intervention Type DRUG

500 mg intramuscularly 2 hours before the procedure

gentamicin

Intervention Type DRUG

2 mg/kg intramuscularly 2 hours before the procedure

amikacin

Intervention Type DRUG

5 mg/kg intramuscularly 2 hours before the procedure

aztreonam

Intervention Type DRUG

500 mg intramuscularly 2 hours before the procedure

imipenem

Intervention Type DRUG

500 mg intramuscularly 2 hours before the procedure

ceftriaxone

Intervention Type DRUG

2000 mg intravenously 1 hour before the procedure

gentamicin

Intervention Type DRUG

2 mg/kg intravenously 1 hour before the procedure

amikacin

Intervention Type DRUG

5 mg/kg intravenously 1 hour before the procedure

aztreonam

Intervention Type DRUG

2000 mg intravenously 1 hour before the procedure

imipenem

Intervention Type DRUG

1000 mg intravenously 1 hour before the procedure

Interventions

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Ciprofloxacin

500 mg orally 2 hours before prostate biopsy

Intervention Type DRUG

trimethoprim-sulfamethoxazole

1 double strength tablet orally 2 hours before the procedure and again 12 hours later

Intervention Type DRUG

cefuroxime

500 mg orally 2 hours before the procedure then again 12 hours later

Intervention Type DRUG

ceftriaxone

500 mg intramuscularly 2 hours before the procedure

Intervention Type DRUG

gentamicin

2 mg/kg intramuscularly 2 hours before the procedure

Intervention Type DRUG

amikacin

5 mg/kg intramuscularly 2 hours before the procedure

Intervention Type DRUG

aztreonam

500 mg intramuscularly 2 hours before the procedure

Intervention Type DRUG

imipenem

500 mg intramuscularly 2 hours before the procedure

Intervention Type DRUG

ceftriaxone

2000 mg intravenously 1 hour before the procedure

Intervention Type DRUG

gentamicin

2 mg/kg intravenously 1 hour before the procedure

Intervention Type DRUG

amikacin

5 mg/kg intravenously 1 hour before the procedure

Intervention Type DRUG

aztreonam

2000 mg intravenously 1 hour before the procedure

Intervention Type DRUG

imipenem

1000 mg intravenously 1 hour before the procedure

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

90 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes