Antibiotic Prophylaxis for PEG in Children

Sponsor

Azienda Policlinico Umberto I (Other)

Overall Status

Unknown status

CT.gov ID

NCT01870167

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

5.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infection	Drug: co-amoxiclav Dietary Supplement: Placebo	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Jan 1, 2013

Anticipated Primary Completion Date :

Jun 1, 2014

Anticipated Study Completion Date :

Jun 1, 2014

Arms and Interventions

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

Arm

Intervention/Treatment

Placebo Comparator: placebo

Placebo

Dietary Supplement: Placebo

Placebo

Experimental: co-amoxiclav

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

Drug: co-amoxiclav

a single iv dose of co-amoxiclav (50/mg/Kg) at the time of PEG insertion.

Outcome Measures

Primary Outcome Measures

Efficacy [24 hours after PEG insertion]
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.
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

Efficacy [24 hours 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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Month to 18 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Pediatrics	Rome		Italy	00161

Sponsors and Collaborators

Azienda Policlinico Umberto I

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Giovanni Di Nardo, MD, Azienda Policlinico Umberto I

ClinicalTrials.gov Identifier:

NCT01870167

Other Study ID Numbers:

Pediatric- PEG

First Posted:

Jun 5, 2013

Last Update Posted:

Jun 5, 2013

Last Verified:

May 1, 2013

Keywords provided by Giovanni Di Nardo, MD, Azienda Policlinico Umberto I

PEG

Percutaneous Endoscopic Gastrostomy

antibiotic prophylaxis

Additional relevant MeSH terms:

Amoxicillin-Potassium Clavulanate Combination

Study Results

No Results Posted as of Jun 5, 2013