Trial Outcomes & Findings for Antibiotic Prophylaxis for Transrectal Prostate Biopsy (NCT NCT01659866)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

563 participants

Primary outcome timeframe

30 days post-biopsy

Results posted on

2019-06-25

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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 Ciprofloxacin: 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
Overall Study STARTED	430	80
Overall Study COMPLETED	430	80
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Antibiotic Prophylaxis for Transrectal Prostate Biopsy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cipro-susceptible n=430 Participants 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	Cipro-resistant n=80 Participants 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 n=510 Participants Total of all reporting groups
Age, Continuous	62.7 years STANDARD_DEVIATION 9.1 • n=5 Participants	61.6 years STANDARD_DEVIATION 7.6 • n=7 Participants	62.4 years STANDARD_DEVIATION 8.8 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	430 Participants n=5 Participants	80 Participants n=7 Participants	510 Participants n=5 Participants
Region of Enrollment United States	430 participants n=5 Participants	80 participants n=7 Participants	510 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days post-biopsy

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Cipro-susceptible n=430 Participants 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	Cipro-resistant n=80 Participants 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
Number of Participants With Post-biopsy Infection.	6 participants	3 participants

Adverse Events

Cipro-susceptible

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cipro-resistant

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Anthony Schaeffer

Northwestern University

Phone: 312-908-1615

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place