Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 4 of 758 for:    Anti-Infective Agents AND Antibiotics, Antitubercular AND culture

Rapid PCR to Guide Antibiotic Therapy at the Time of 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: NCT03040050
Recruitment Status : Active, not recruiting
First Posted : February 1, 2017
Last Update Posted : June 10, 2019
Sponsor:
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

Tracking Information
First Submitted Date  ICMJE January 27, 2017
First Posted Date  ICMJE February 1, 2017
Last Update Posted Date June 10, 2019
Actual Study Start Date  ICMJE January 1, 2017
Estimated Primary Completion Date January 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2017)
Results of rapid qPCR to determine standard of care antibiotic prophylaxis for prostate biopsy. [ Time Frame: Day of prostate biopsy ]
Reduction in dual antibiotic prophylaxis in the intervention vs.usual care groups.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03040050 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2017)
  • Determine if rapid qPCR test results in longer patient wait times. [ Time Frame: Day of prostate biopsy ]
    Difference in the amount of time the PCR technique takes compared to the fastest workflow (physician chooses no additional antibiotics).
  • Determine if rPCR results and standard rectal culture results are the same. [ Time Frame: 1 week ]
    Comparison of rPCR results to standard rectal culture on Fluoroquinolone infused MacConkey agar.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rapid PCR to Guide Antibiotic Therapy at the Time of Prostate Biopsy
Official Title  ICMJE Rapid PCR to Guide Antibiotic Therapy at the Time of Prostate Biopsy
Brief Summary The study is a randomized controlled trial. Subjects are randomly assigned 1:1 to receive either rapid multiplex qPCR (intervention) prior to standard of care prostate biopsy or standard of care (control) prostate biopsy. The subjects will have a rectal culture swab performed prior to the prostate biopsy. One rectal culture swab will be used for rapid multiplex qPCR and the other swab will be sent to microbiology for a standard culture. The subjects randomized to the intervention group will have the qPCR results shared with the physician to determine if additional standard of care antibiotics are needed at time of standard of care prostate biopsy. The subjects randomized to the control group will not have the qPCR results shared with the physician to determine if additional standard of care antibiotics are needed at time of standard of care prostate biopsy. Approximately, 10 days after the prostate biopsy, the research staff will conduct a chart review and/or telephone call to ask about any prostate biopsy infections and complications.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Care Provider, Investigator)
Masking Description:
The rPCR results will be provided to the clinical provider for the Interventional group participants. The rPCR results will not be provided to the clinic provider for the control group participants.
Primary Purpose: Prevention
Condition  ICMJE
  • Antibiotic Therapy
  • Prostate Biopsy
Intervention  ICMJE
  • Other: rPCR results
    Interventional group: rPCR results will be shared with the clinical provider to determine appropriate standard of care antibiotic treatment at time of standard of care prostate biopsy.
  • Other: Control group
    Control group: rPCR results will not be shared with the clinical provider at time of standard of care prostate biopsy. Standard of care antibiotic selection will be up to the discretion of the clinical provider.
Study Arms  ICMJE
  • Men scheduled for prostate biopsy randomized to Control
    Intervention: Other: Control group
  • Experimental: Men scheduled for a prostate biopsy randomized to Intervention
    Intervention: Other: rPCR results
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: January 31, 2017)
136
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2025
Estimated Primary Completion Date January 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Be able to give informed consent
  • Be age 50 or older
  • Recommended to undergo a prostate biopsy
  • No allergy or side effect to fluoroquinolone antibiotics
  • No history of prostate biopsy infection
  • No hepatic or renal insufficiency in which fluoroquinolone antibiotics are contraindicated.

Exclusion Criteria:

  • Unable to give informed consent
  • Age < 50
  • Not recommended to have prostate biopsy
  • Allergic to or have side effects to fluoroquinolone antibiotics
  • History of prostate biopsy infection
  • Hepatic or renal insufficiency in which fluoroquinolones antibiotics are contraindicated.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03040050
Other Study ID Numbers  ICMJE 16-386
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party The University of Texas Health Science Center at San Antonio
Study Sponsor  ICMJE The University of Texas Health Science Center at San Antonio
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael Liss, MD University of Texas Health Science Center San Antonio
PRS Account The University of Texas Health Science Center at San Antonio
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP