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A Trial Assessing Peri-procedure Chemoprophylaxis During Transrectal Prostate Needle Biopsy

NCT02423759 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 510

Last updated 2017-04-04

No results posted yet for this study

Summary

The aim of the study is to evaluate whether changing antibiotic prophylaxis from fluoroquinolones alone to fluoroquinolones plus gentamicin 160mg single IM dose or targeted antibiotic prophylaxis according to rectal swab culture would influence infectious complication rates in those men undergoing transrectal ultrasound-guided prostate biopsy.

Conditions

  • Benign Prostate Hyperplasia

Interventions

DRUG

ciprofloxacin

500mg ciprofloxacin twice daily starting the day before biopsy and continued for 3 days after

DRUG

ciprofloxacin and gentamycine

standard chemoprophylaxis plus gentamicin 160mg intramuscular once just before the biopsy

DRUG

culture based chemoprophylaxis

Patients will receive antibiotic according to rectal swab culture at time of biopsy and then after for 3 days.

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Principal Investigators

  • Ahmed M Elshal, MD · Mansoura University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2017-01-16
Completion
2017-04-01

Countries

  • Egypt

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02423759 on ClinicalTrials.gov