Antibiotic Prophylaxis for PEG in Children

Phase 4

• Conditions: Infection
• Interventions: Dietary Supplement: Placebo; Drug: co-amoxiclav

• Registration Number: NCT01870167
• Lead Sponsor: Azienda Policlinico Umberto I

Brief Summary

The aim of this study is to evaluate if a single i.v. dose of co-amoxiclav before PEG can reduce the incidence of peristomal wound infection in the paediatric population.

Detailed Description

Percutaneous Endoscopic Gastrostomy (PEG) is a common endoscopic procedure, performed to avoid malnutrition in various pathological conditions.

Gastrostomy tube placement is associated with intra and postoperative complications both in the adult and in the paediatric population.

Local infection is the most common complication following PEG.

Antibiotic prophylaxis is a well-established strategy to reduce peristomal wound infection rate in adult population.

The aim of this study is to evaluate if a single i.v. dose of co-amoxiclav before PEG can reduce the incidence of peristomal wound infection in the paediatric population.

Study Timeline

• Study Start: 2013-01
• Status Verified: 2013-05
• Study First Submitted: 2013-05-14
• Study First Submitted QC: 2013-06-04
• Last Update Submitted: 2013-06-04
• Study First Posted: 2013-06-05
• Last Update Posted: 2013-06-05
• Primary Completion: 2014-06
• Study Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• All pediatric patients (0-18 years) who will refer for PEG placement to the endoscopy unit

Exclusion Criteria

• Controindications for PEG
• Ongoing antibiotic treatment
• Antibiotic use within the past 4 days
• Illness too severe to allow the patient to participate
• Allergy to penicillin

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	Placebo
co-amoxiclav	co-amoxiclav	co-amoxiclav is a combination antibiotic consisting of amoxicillin trihydrate, a β-lactam antibiotic, and potassium clavulanate, a β-lactamase inhibitor

Primary Outcome Measures

Name	Time	Method
Efficacy	14 days after PEG insertion	14 days after PEG insertion PEG site will be examined for erythema, induration and exudate and scored using the peristomal sepsis scoring system.

Secondary Outcome Measures

Name	Time	Method
Efficacy	14 days after PEG insertion	Secondary outcomes are occurrence of systemic infection, defined as persistent fever (temperature \>38.0 °C for \>24 h) or clinical, laboratory and microbiological evidence of invasive sepsis and objective signs of infection, including a positive bacterial or fungal culture, high levels of highly sensitive C reactive protein, and a high white blood cell count.

Trial Locations

Locations (1)

Department of Pediatrics; 🇮🇹 Rome, Italy