- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01870167
Antibiotic Prophylaxis for PEG in Children
Antibiotic Prophylaxis for Percutaneous Endoscopic Gastrostomy (PEG) in Children: a Randomised Controlled Trial.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Rome, Italy, 00161
- Recruiting
- Department of Pediatrics
-
Contact:
- Department of Pediatrics
- Phone Number: 0649979326
- Email: giovanni.dinardo@uniroma1.it
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: placebo
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
|
a single iv dose of co-amoxiclav (50/mg/Kg) at the time of PEG insertion.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy
Time Frame: 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. |
24 hours after PEG insertion
|
Efficacy
Time Frame: 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.
|
14 days after PEG insertion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy
Time Frame: 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.
|
24 hours after PEG insertion
|
Efficacy
Time Frame: 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.
|
14 days after PEG insertion
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pediatric- PEG
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Infection
-
West Virginia UniversityEnrolling by invitationSkin and Soft Tissue Infection | Gastrointestinal Infection | Pulmonary Infection | Bone and Joint Infection | Endovascular Infection | Genitourinary InfectionUnited States
-
Ondine Biomedical Inc.CompletedSurgical Site Infection | Nosocomial Infection | Healthcare Associated InfectionUnited States
-
Gundersen Lutheran Medical FoundationGundersen Lutheran Health SystemCompletedSurgical Site Infection | Superficial Surgical Site Infection | Deep Surgical Site Infection | Organ/Space Surgical Site InfectionUnited States
-
Croydon Health Services NHS TrustCompletedSurgical Site Infection | Wound Infection | Cesarean Section; Infection | Perineal InfectionUnited Kingdom
-
Cairo UniversityRecruitingPostoperative Infection | Cesarean Section Complications | Vaginal InfectionEgypt
-
Vastra Gotaland RegionGöteborg UniversityRecruitingProsthetic Joint Infection | Hip Prosthesis Infection | Prosthetic Infection | Knee Prosthesis InfectionSweden
-
University of ZurichRecruitingProsthetic Joint Infection | Surgical Site Infection | Prosthesis and Implants | Postoperative Wound Infection Deep Incisional Surgical SiteSwitzerland
-
Ondine Biomedical Inc.CompletedNosocomial Infection | Surgical Site Infections | Healthcare Associated InfectionsUnited States
-
Duke UniversityAgency for Healthcare Research and Quality (AHRQ)CompletedSurgical Site Infection | Infection ControlUnited States
-
Leiden University Medical CenterRadboud University Medical Center; University Medical Center Groningen; Erasmus... and other collaboratorsRecruitingProsthetic-joint Infection | Infection Hip | Infection; Knee, JointNetherlands
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States