Rapid PCR to Guide Antibiotic Therapy at the Time of Prostate Biopsy

NCT ID: NCT03040050

Last Updated: 2020-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2019-07-02

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.

Conditions

Antibiotic Therapy; Prostate Biopsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Men scheduled for prostate biopsy randomized to Control

Group Type: OTHER

Control group

Intervention Type: OTHER

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.

Men scheduled for a prostate biopsy randomized to Intervention

Group Type: EXPERIMENTAL

rPCR results

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Liss, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Health Science Center San Antonio

Locations

South Texas Veterans Health Care

San Antonio, Texas, United States

Countries

United States

Other Identifiers

16-386

Identifier Type: -

Identifier Source: org_study_id