Antibiotic Prophylaxis for PEG in Children

Study Overview
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Brief Summary
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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
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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.

Official Title
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Antibiotic Prophylaxis for Percutaneous Endoscopic Gastrostomy (PEG) in Children: a Randomised Controlled Trial.

Conditions
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Infection

Intervention / Treatment
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* Drug: co-amoxiclav
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>Placebo | Dietary Supplement: Placebo<br>* Placebo<br>|
| Experimental: co-amoxiclav<br>co-amoxiclav is a combination antibiotic consisting of amoxicillin trihydrate, a β-lactam antibiotic, and potassium clavulanate, a β-lactamase inhibitor | Drug: co-amoxiclav<br>* a single iv dose of co-amoxiclav (50/mg/Kg) at the time of PEG insertion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy | 24 hours after PEG insertion PEG site will be examined for erythema, induration and exudate and scored using the peristomal sepsis scoring system. PEG site infection will be defined as presence of pus or a score of 8 or more, with or without microbiological evidence of bacterial or fungal infection from PEG site swabs. | 24 hours after PEG insertion | 
| Efficacy | 14 days after PEG insertion PEG site will be examined for erythema, induration and exudate and scored using the peristomal sepsis scoring system. | 14 days after PEG insertion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy | 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. | 24 hours after PEG insertion | 
| Efficacy | 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. | 14 days after PEG insertion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PEG, Percutaneous Endoscopic Gastrostomy, antibiotic prophylaxis