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Completed

NCT Number: NCT01659866

Antibiotic Prophylaxis for Transrectal Prostate Biopsy

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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Key information

Conditions

Infection Infections

Age range

30 year–90 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Northwestern University Department of Urology

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ciprofloxacin

Drug

500 mg orally 2 hours before prostate biopsy

Trimethoprim-sulfamethoxazole

Drug

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

cefuroxime

Drug

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

Ceftriaxone

Drug

500 mg intramuscularly 2 hours before the procedure

Gentamicin

Drug

2 mg/kg intramuscularly 2 hours before the procedure

Amikacin

Drug

5 mg/kg intramuscularly 2 hours before the procedure

Aztreonam

Drug

500 mg intramuscularly 2 hours before the procedure

Imipenem

Drug

500 mg intramuscularly 2 hours before the procedure

Primary outcomes

  1. Number of Participants With Post-biopsy Infection.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

Evaluation of Directed Antimicrobial Prophylaxis for Transrectal Ultrasound Guided Prostate Biopsy (TRUSP)

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Aug 8, 2012
Registry last updated
Jun 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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