Antibiotic Prophylaxis for Transrectal Prostate Biopsy

NCT01659866 | Completed Phase 4 Results

• 2 other identifiers: STU00059558EAM-237
• Study Type: interventional
• Target: 563
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Infection

Keywords

Infection; Antibiotic resistance; Prostate biopsy

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Post-biopsy Infection.

  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.

  30 days post-biopsy

Study Arms (2)

Cipro-susceptible

OTHER

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

Cipro-resistant

ACTIVE COMPARATOR

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; Drug: cefuroxime; Drug: ceftriaxone; Drug: gentamicin; Drug: amikacin; Drug: aztreonam; Drug: imipenem

Interventions

Ciprofloxacin DRUG

500 mg orally 2 hours before prostate biopsy

Cipro-susceptible

trimethoprim-sulfamethoxazole DRUG

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

Cipro-resistant

cefuroxime DRUG

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

Cipro-resistant

ceftriaxone DRUG

500 mg intramuscularly 2 hours before the procedure

Cipro-resistant

gentamicin DRUG

2 mg/kg intramuscularly 2 hours before the procedure

Cipro-resistant

amikacin DRUG

5 mg/kg intramuscularly 2 hours before the procedure

Cipro-resistant

aztreonam DRUG

500 mg intramuscularly 2 hours before the procedure

Cipro-resistant

imipenem DRUG

500 mg intramuscularly 2 hours before the procedure

Cipro-resistant

Eligibility Criteria

• Age: 30 Years - 90 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University Department of Urology

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• Zembower TR, Maxwell KM, Nadler RB, Cashy J, Scheetz MH, Qi C, Schaeffer AJ. Evaluation of targeted antimicrobial prophylaxis for transrectal ultrasound guided prostate biopsy: a prospective cohort trial. BMC Infect Dis. 2017 Jun 7;17(1):401. doi: 10.1186/s12879-017-2470-1.

  PMID: 28592230 DERIVED

MeSH Terms

Conditions

Infections

Interventions

Ciprofloxacin; Trimethoprim, Sulfamethoxazole Drug Combination; Cefuroxime; Ceftriaxone; Gentamicins; Amikacin; Aztreonam; Imipenem

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Sulfamethoxazole; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Trimethoprim; Pyrimidines; Heterocyclic Compounds, 1-Ring; Drug Combinations; Pharmaceutical Preparations; Cephalosporins; beta-Lactams; Lactams; Thiazines; Cefotaxime; Cephacetrile; Aminoglycosides; Glycosides; Carbohydrates; Kanamycin; Monobactams; Thienamycins; Carbapenems

Limitations and Caveats

Did not reach recruiting targets due to fewer prostate biopsies being performed than originally estimated in the study period.

Results Point of Contact

• Title: Dr. Anthony Schaeffer
• Organization: Northwestern University

ajschaeffer@northwestern.edu

312-908-1615

Study Officials

• Anthony J Schaeffer, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Herman L. Kretschmer Professor and Chair, Department of Urology

Study Record Dates

• First Submitted: July 9, 2012
• First Posted: August 8, 2012
• Study Start: August 1, 2012
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2016
• Last Updated: June 25, 2019
• Results First Posted: June 25, 2019

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)