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Trial record 61 of 751 for:    Anti-Infective Agents AND Antibiotics, Antitubercular AND culture

Antibiotic Prophylaxis for Transrectal Prostate Biopsy

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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

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 563 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
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Biopsy

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




Primary Outcome Measures :
  1. Number of Participants With Post-biopsy Infection. [ Time Frame: 30 days post-biopsy ]
    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.



Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01659866


Locations
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United States, Illinois
Northwestern University Department of Urology
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
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Principal Investigator: Anthony J Schaeffer, MD Northwestern University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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    Key Record Dates
Results First Posted: June 25, 2019
Last Update Posted: June 25, 2019
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Anthony Schaeffer, Northwestern University:
Infection
Antibiotic resistance
Prostate biopsy
Additional relevant MeSH terms:
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Trimethoprim, Sulfamethoxazole Drug Combination
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Anti-Infective Agents, Urinary
Renal Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Dyskinesia Agents
Infection
Ciprofloxacin
Gentamicins
Ceftriaxone
Imipenem
Amikacin
Aztreonam
Cefuroxime
Cefuroxime axetil
Trimethoprim
Sulfamethoxazole
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Protein Synthesis Inhibitors
Antimalarials
Folic Acid Antagonists
Cytochrome P-450 CYP2C8 Inhibitors