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

NCT02423759 | Completed Phase 4 DMC

• 1 other identifier: MANS-2015-03
• Study Type: interventional
• Target: 510
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Chemoprevention

Outcome Measures

Primary Outcomes (1)

• occurrence of post procedure infectious complications

  occurrence of post procedure infectious complications (e.g urosepsis and local genital or prostate infectious complications). Sepsis is identified as occurrence of two or more of SIRS criteria.

  2 weeks

Secondary Outcomes (2)

• flouroquinolones resistance in rectal carriage

  2 weeks

• post procedure non-infectious complications

  2 weeks

Study Arms (3)

ciprofloxacin

ACTIVE COMPARATOR

standard chemoprophylaxis \[500mg ciprofloxacin twice daily for 3 days\]

Drug: ciprofloxacin

ciprofloxacin and gentamycine

EXPERIMENTAL

Augmented Chemoprophylaxis \[standard chemoprophylaxis plus 160mg\]

Drug: ciprofloxacin and gentamycine

culture based chemoprophylaxis

EXPERIMENTAL

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

Drug: culture based chemoprophylaxis

Interventions

ciprofloxacin DRUG

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

Also known as: standard chemoprophylaxis

ciprofloxacin

ciprofloxacin and gentamycine DRUG

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

Also known as: standard chemoprophylaxis plus gentamicin

ciprofloxacin and gentamycine

culture based chemoprophylaxis DRUG

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

culture based chemoprophylaxis

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Prothrombin concentration \> 70%
• Platelet count \> 100.000/cm

You may not qualify if:

• Acute prostatitis (positive symptoms and signs)
• Patients with compromised renal function (serum creatinine \>1.6 mg/dl)
• Uncontrolled DM
• Patients on immunosuppressive therapy
• Active steroid intake
• Untreated bleeding diathesis

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Urology and Nprhology Center

Al Mansurah, Aldakahlia, 35516, Egypt

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Ciprofloxacin; Gentamicins

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Ahmed M Elshal, MD

  Mansoura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: March 24, 2015
• First Posted: April 22, 2015
• Study Start: April 1, 2015
• Primary Completion: January 16, 2017
• Study Completion: April 1, 2017
• Last Updated: April 4, 2017

Record last verified: 2017-04

Locations

EG (1)