Antibiotic Prophylaxis for PEG in Children

Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01870167
• Other study ID #: Pediatric- PEG
• Status: Recruiting
• Phase: Phase 4
• First received: May 14, 2013
• Last updated: June 4, 2013
• Start date: January 2013
• Est. completion date: June 2014

Study information

• Verified date: May 2013
• Source: Azienda Policlinico Umberto I
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 18 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infection

Intervention

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

Dietary Supplement:
• Placebo
Placebo

Locations

Country	Name	City	State
Italy	Department of Pediatrics	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Policlinico Umberto I

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No