NCT01870167

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2013

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 5, 2013

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

June 5, 2013

Status Verified

May 1, 2013

Enrollment Period

1.4 years

First QC Date

May 14, 2013

Last Update Submit

June 4, 2013

Conditions

Infection

Keywords

PEGPercutaneous Endoscopic Gastrostomyantibiotic prophylaxis

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Efficacy

    24 hours after PEG insertion

  • Efficacy

    14 days after PEG insertion

Study Arms (2)

placebo

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

co-amoxiclav

EXPERIMENTAL

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

Drug: co-amoxiclav

Interventions

co-amoxiclavDRUG

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

co-amoxiclav
PlaceboDIETARY_SUPPLEMENT

Placebo

placebo

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • All pediatric patients (0-18 years) who will refer for PEG placement to the endoscopy unit

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Pediatrics

Rome, 00161, Italy

RECRUITING

MeSH Terms

Conditions

Infections

Interventions

Amoxicillin-Potassium Clavulanate Combination

Intervention Hierarchy (Ancestors)

Clavulanic AcidClavulanic Acidsbeta-LactamsLactamsAmidesOrganic ChemicalsAmoxicillinAmpicillinPenicillin GPenicillinsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDrug CombinationsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 14, 2013

First Posted

June 5, 2013

Study Start

January 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

June 5, 2013

Record last verified: 2013-05

Locations

IT(1)