Antibiotic Prophylaxis for Transrectal Prostate Biopsy

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Northwestern University
Sponsor:
Information provided by (Responsible Party):
Anthony Schaeffer, Northwestern University
ClinicalTrials.gov Identifier:
NCT01659866
First received: July 9, 2012
Last updated: April 16, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Infection
Drug: Ciprofloxacin
Drug: trimethoprim-sulfamethoxazole
Drug: cefuroxime
Drug: ceftriaxone
Drug: gentamicin
Drug: amikacin
Drug: aztreonam
Drug: imipenem
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Directed Antimicrobial Prophylaxis for Transrectal Ultrasound Guided Prostate Biopsy (TRUSP)

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Infection rates [ Time Frame: 7 days post-biopsy ] [ Designated as safety issue: No ]
    To measure and compare the rates of infection following TRUSP in subjects with and without CR-GNB


Secondary Outcome Measures:
  • Infection rate [ Time Frame: 30 days post-biopsy ] [ Designated as safety issue: No ]
    To measure and compare the rates of infection following TRUSP in subjects with and without CR-GNB

  • Demographics and medical co-morbidities [ Time Frame: Study day 1 ] [ Designated as safety issue: No ]
    Certain demographics and medical co-morbidities may predispose to infection following prostate biopsy. As such, these will be measured and compared among the ciprofloxacin susceptible and resistant groups. The demographics include age and ethnicity and the co-morbidities include reason for biopsy, past exposure to antibiotics within 2 years of the biopsy, exposure to a healthcare facility within the last year, any prior infection after prostate biopsy, and history of urinary traction infection or urinary retention.

  • Genus and species of rectal swab isolates with their antibiotic susceptibility profiles [ Time Frame: Study day 7 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Cost of care [ Time Frame: 30 days post-biopsy ] [ Designated as safety issue: No ]
    To determine and compare the overall cost of care among the two groups


Estimated Enrollment: 1700
Study Start Date: August 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: Ciprofloxacin
500 mg orally 2 hours before prostate biopsy
Active Comparator: 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
Drug: trimethoprim-sulfamethoxazole
1 double strength tablet orally 2 hours before the procedure and again 12 hours later
Drug: cefuroxime
500 mg orally 2 hours before the procedure then again 12 hours later
Drug: ceftriaxone
500 mg intramuscularly 2 hours before the procedure
Drug: gentamicin
2 mg/kg intramuscularly 2 hours before the procedure
Drug: amikacin
5 mg/kg intramuscularly 2 hours before the procedure
Drug: aztreonam
500 mg intramuscularly 2 hours before the procedure
Drug: imipenem
500 mg intramuscularly 2 hours before the procedure
Drug: ceftriaxone
2000 mg intravenously 1 hour before the procedure
Drug: gentamicin
2 mg/kg intravenously 1 hour before the procedure
Drug: amikacin
5 mg/kg intravenously 1 hour before the procedure
Drug: aztreonam
2000 mg intravenously 1 hour before the procedure
Drug: imipenem
1000 mg intravenously 1 hour before the procedure

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.

  Eligibility

Ages Eligible for Study:   30 Years to 90 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01659866

Contacts
Contact: Anthony J Schaeffer, MD (312) 908-9844 ajschaeffer@northwestern.edu
Contact: Teresa R Zembower, MD (312) 926-8358 t-zembower@northwestern.edu

Locations
United States, Illinois
Northwestern University Department of Urology Recruiting
Chicago, Illinois, United States, 60611
Contact: Anthony J Schaeffer, MD    312-908-1615    ajschaeffer@northwestern.edu   
Contact: Teresa R Zembower, MD    (312) 926-8358    t-zembower@northwestern.edu   
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Anthony J Schaeffer, MD Northwestern University
  More Information

No publications provided

Responsible Party: Anthony Schaeffer, Herman L. Kretschmer Professor and Chair, Department of Urology, Northwestern University
ClinicalTrials.gov Identifier: NCT01659866     History of Changes
Other Study ID Numbers: STU00059558, EAM-237
Study First Received: July 9, 2012
Last Updated: April 16, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Northwestern University:
Infection
Antibiotic resistance
Prostate biopsy

Additional relevant MeSH terms:
Amikacin
Anti-Bacterial Agents
Aztreonam
Ceftriaxone
Cefuroxime
Cefuroxime axetil
Ciprofloxacin
Gentamicins
Imipenem
Sulfamethoxazole
Trimethoprim
Trimethoprim-Sulfamethoxazole Combination
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Protein Synthesis Inhibitors
Anti-Infective Agents, Urinary
Renal Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists

ClinicalTrials.gov processed this record on July 31, 2014