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Infection | Antibiotic Prophylaxis for PEG in Children

Infection research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Infection

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

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

Dietary Supplement:PlaceboPlacebo

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

placeboPlacebo

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

Study Status

Unknown status

Start Date: January 2013

Completed Date: June 2014

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Efficacy

Secondary Outcome: Efficacy

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor: Azienda Policlinico Umberto I

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01870167

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