Antibiotic Prophylaxis for Transrectal Prostate Biopsy

Status Completed

Clinical Trial 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.

Clinical Trial 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

Related Conditions & MeSH terms

Infection

Clinical Trial Details

NCT number	NCT01659866
Study type	Interventional
Source	Northwestern University
Contact
Status	Completed
Phase	Phase 4
Start date	August 2012
Completion date	August 2016

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04529421` - Assocation Between In-person Instruction and COVID-19 Risk
Recruiting	`NCT04081792` - Optimal Antibiotics for Operated Diabetic Foot Infections	N/A
Completed	`NCT04332861` - Evaluation of Infection in Obstructing Urolithiasis
Recruiting	`NCT04674657` - Does Extra-Corporeal Membrane Oxygenation Alter Antiinfectives Therapy Pharmacokinetics in Critically Ill Patients
Enrolling by invitation	`NCT05052203` - Researching the Effects of Sepsis on Quality Of Life, Vitality, Epigenome and Gene Expression During RecoverY From Sepsis
Recruiting	`NCT00342589` - New Techniques for Using a Saline Wash as a Diagnostic Tool for Pneumocystis Pneumonia
Completed	`NCT03295825` - Heparin Binding Protein in Early Sepsis Diagnosis	N/A
Completed	`NCT03296423` - Bacillus Calmette-guérin Vaccination to Prevent Infections of the Elderly	Phase 4
Withdrawn	`NCT04217252` - Clinical Application of High-throughput Sequencing Technology for the Diagnosis of Patients With Severe Infection	N/A
Recruiting	`NCT02899143` - Short-course Antimicrobial Therapy in Sepsis	Phase 2
Recruiting	`NCT02905552` - Myelodysplasic Syndromes and Risk Factors for Infection	N/A
Withdrawn	`NCT02904434` - Gastrointestinal Implications of Voriconazole Exposure
Active, not recruiting	`NCT02768454` - Antimicrobials Stewardship by Pharmacist	N/A
Completed	`NCT02219776` - Decreasing Infection In Arthroscopic Shoulder Surgery	N/A
Completed	`NCT02210169` - RCT of Continuous Versus Intermittent Infusion of Vancomycin in Neonates	N/A
Recruiting	`NCT02098226` - Evaluation of MALDI Biotyper CA System for Detection of Gram- and Gram+ Bacteria and Yeasts	N/A
Completed	`NCT01846832` - A Study of TMC435 Plus Pegylated Interferon Alfa-2a and Ribavirin in Participants With Chronic HCV Infection	Phase 3
Completed	`NCT01434797` - Value of PET/CT Imaging in the Diagnosis of Permanent Central Venous Catheters Infection
Terminated	`NCT01441206` - Safety and Pharmacokinetics of Single and Multiple Dose Rifampin in Infants	Phase 1
Completed	`NCT01159834` - Human Papillomavirus (HPV) Vaccination in Barretos (Pio XII Foundation - Barretos Cancer Hospital)	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.