Antibiotic Prophylaxis for PEG in Children

Azienda Policlinico Umberto I

Status and phase: Unknown; Phase 4

Conditions: Infection

Treatments: Drug: co-amoxiclav; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01870167

Pediatric- PEG

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 1 month to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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90 participants in 2 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Dietary Supplement: Placebo

co-amoxiclav

Experimental group

Description:

co-amoxiclav is a combination antibiotic consisting of amoxicillin trihydrate, a β-lactam antibiotic, and potassium clavulanate, a β-lactamase inhibitor

Treatment:

Drug: co-amoxiclav