Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 61 of 752 for:    Anti-Infective Agents AND Antibiotics, Antitubercular AND culture

Antibiotic Prophylaxis for Transrectal Prostate Biopsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01659866
Recruitment Status : Completed
First Posted : August 8, 2012
Results First Posted : June 25, 2019
Last Update Posted : June 25, 2019
Sponsor:
Information provided by (Responsible Party):
Anthony Schaeffer, Northwestern University

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Infection
Interventions Drug: Ciprofloxacin
Drug: trimethoprim-sulfamethoxazole
Drug: cefuroxime
Drug: ceftriaxone
Drug: gentamicin
Drug: amikacin
Drug: aztreonam
Drug: imipenem
Enrollment 563
Recruitment Details  
Pre-assignment Details 563 patients consented and of these, 53 were excluded as follows: 16 patients had issues with informed consent, 20 received antimicrobials off protocol, 16 did not undergo TRUSP and 1 was lost to follow up. Thus 510 patients underwent swabs; 430 had CS isolates while 80 had CR isolates. All 510 patients completed the study.
Arm/Group Title Cipro-susceptible Cipro-resistant
Hide Arm/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

Ciprofloxacin: 500 mg orally 2 hours before prostate biopsy

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
Period Title: Overall Study
Started 430 80
Completed 430 80
Not Completed 0 0
Arm/Group Title Cipro-susceptible Cipro-resistant Total
Hide Arm/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

Ciprofloxacin: 500 mg orally 2 hours before prostate biopsy

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
Total of all reporting groups
Overall Number of Baseline Participants 430 80 510
Hide Baseline Analysis Population Description
Men >/= 18 scheduled for transrectal prostate biopsy who signed consent underwent a rectal swab culture to determine whether they harbored ciprofloxacin-susceptible or -resistant flora. Antimicrobial prophylaxis was chosen based on this result, and patients were followed for 30 days to see if they developed an infection post-procedure.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 430 participants 80 participants 510 participants
62.7  (9.1) 61.6  (7.6) 62.4  (8.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 430 participants 80 participants 510 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
430
 100.0%
80
 100.0%
510
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 430 participants 80 participants 510 participants
430 80 510
1.Primary Outcome
Title Number of Participants With Post-biopsy Infection.
Hide Description 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.
Time Frame 30 days post-biopsy
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 563 patients who signed consent, 53 were excluded; thus, 510 patients participated in the study. Of these 510, 430 harbored ciprofloxacin-susceptible flora and 80 harbored ciprofloxacin-resistant flora.
Arm/Group Title Cipro-susceptible Cipro-resistant
Hide Arm/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

Ciprofloxacin: 500 mg orally 2 hours before prostate biopsy

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
Overall Number of Participants Analyzed 430 80
Measure Type: Number
Unit of Measure: participants
6 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cipro-susceptible, Cipro-resistant
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Time Frame 30 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cipro-susceptible Cipro-resistant
Hide Arm/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

Ciprofloxacin: 500 mg orally 2 hours before prostate biopsy

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
All-Cause Mortality
Cipro-susceptible Cipro-resistant
Affected / at Risk (%) Affected / at Risk (%)
Total   0/430 (0.00%)   0/80 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Cipro-susceptible Cipro-resistant
Affected / at Risk (%) Affected / at Risk (%)
Total   0/430 (0.00%)   0/80 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cipro-susceptible Cipro-resistant
Affected / at Risk (%) Affected / at Risk (%)
Total   0/430 (0.00%)   0/80 (0.00%) 
Did not reach recruiting targets due to fewer prostate biopsies being performed than originally estimated in the study period.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Anthony Schaeffer
Organization: Northwestern University
Phone: 312-908-1615
EMail: ajschaeffer@northwestern.edu
Layout table for additonal information
Responsible Party: Anthony Schaeffer, Northwestern University
ClinicalTrials.gov Identifier: NCT01659866     History of Changes
Other Study ID Numbers: STU00059558
EAM-237 ( Other Identifier: Excellence in Academic Medicine )
First Submitted: July 9, 2012
First Posted: August 8, 2012
Results First Submitted: September 23, 2016
Results First Posted: June 25, 2019
Last Update Posted: June 25, 2019