Antibiotic Prophylaxis for Transrectal Prostate Biopsy

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Infection	Drug: Ciprofloxacin; Drug: trimethoprim-sulfamethoxazole; Drug: cefuroxime; Drug: ceftriaxone; Drug: gentamicin; Drug: amikacin; Drug: aztreonam; Drug: imipenem	Phase 4

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	540 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Evaluation of Directed Antimicrobial Prophylaxis for Transrectal Ultrasound Guided Prostate Biopsy (TRUSP)
Study Start Date :	August 2012
Actual Primary Completion Date :	August 2015
Estimated Study Completion Date :	August 2016

Arms and Interventions

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Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. Infection rates [ Time Frame: 7 days post-biopsy ]
   To measure and compare the rates of infection following TRUSP in subjects with and without CR-GNB

Secondary Outcome Measures :

1. Infection rate [ Time Frame: 30 days post-biopsy ]
   To measure and compare the rates of infection following TRUSP in subjects with and without CR-GNB
2. Demographics and medical co-morbidities [ Time Frame: Study day 1 ]
   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.
3. Genus and species of rectal swab isolates with their antibiotic susceptibility profiles [ Time Frame: Study day 7 ]

Other Outcome Measures:

1. Cost of care [ Time Frame: 30 days post-biopsy ]
   To determine and compare the overall cost of care among the two groups

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	30 Years to 90 Years (Adult, Senior)
Sexes 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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Illinois
Northwestern University Department of Urology
Chicago, Illinois, United States, 60611

Sponsors and Collaborators

Northwestern University

Investigators

Principal Investigator:	Anthony J Schaeffer, MD	Northwestern University

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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 ( Other Identifier: Excellence in Academic Medicine )
First Posted:	August 8, 2012
Last Update Posted:	January 14, 2016
Last Verified:	January 2016

Keywords provided by Anthony Schaeffer, Northwestern University:

Infection; Antibiotic resistance; Prostate biopsy

Additional relevant MeSH terms:

Anti-Bacterial Agents; Ciprofloxacin; Gentamicins; Ceftriaxone; Imipenem; Amikacin; Cefuroxime; Cefuroxime axetil; Aztreonam; Trimethoprim, Sulfamethoxazole Drug Combination; Trimethoprim; Sulfamethoxazole; Anti-Infective Agents; Topoisomerase II Inhibitors	Topoisomerase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Cytochrome P-450 CYP1A2 Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Anti-Infective Agents, Urinary; Renal Agents; Antimalarials; Antiprotozoal Agents; Antiparasitic Agents; Folic Acid Antagonists; Cytochrome P-450 CYP2C8 Inhibitors