the Impact of Paediatric Use of Proton Pump Inhibitors on the Risk of Community Acquired Infections. (UTOPIE)

A Cohort Study to Assess the Impact of Paediatric Use of Proton Pump Inhibitors on the Risk of Community Acquired Infections

Pharmacological treatment of physiologic Gastro-esophageal Reflux disease (GERD) is excessive in France, as 65%-85% of children below 11 years are being treated, frequently with Proton Pump Inhibitors (PPIs) PPI have been associated, in adults, with an increase of infection rate but data in pediatry are scarce, especially in community medecine. Recently a study conducted in England brought up controversial results suggesting that the use of PPIs can be associated with a reduced risk of community acquired pneumonia.

Our study was aimed to assess, on a population-based database, the association between PPI prescription and community infections in children of 11 years or under.

Study Overview

• Status: Completed
• Conditions: Community Infections
• Intervention / Treatment: Other: all children with at least one prescription of PPI; Other: all children with no prescription of PPI

• Study Type: Observational
• Enrollment (Actual): 290286

Contacts and Locations

Study Locations

• France
  • Dijon, France, 21079
    • CHU de Dijon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 11 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

all children included in the LDP-CSD database (Cegedim©) aged 11 or below, between 01/01/2008 and 31/12/2013

Description

Inclusion Criteria:

• Children aged 11 years or below with at least 2 consultations during the follow up

Exclusion Criteria:

• chronic pulmonary or cardiac
• muscoviscidosis
• immunodeficiency
• H. pylori infection
• Diabetes
• Denutrition
• known digestive upper tract malformation

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PPI exposed children; all children with at least one prescription of PPI	Other: all children with at least one prescription of PPI; all children with at least one prescription of PPI
non-exposed children; all children with no prescription of PPI	Other: all children with no prescription of PPI; all children with no prescription of PPI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of overall infections	Comparison of number of infections between PPI exposed and non-exposed children. All infections are taken in account	4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of specific infections	Comparison of number of infections between PPI exposed and non-exposed	4 years

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: April 26, 2017
• First Submitted That Met QC Criteria: April 28, 2017
• First Posted (Actual): May 1, 2017

Study Record Updates

• Last Update Posted (Actual): May 1, 2017
• Last Update Submitted That Met QC Criteria: April 28, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Community-Acquired Infections
• Other Study ID Numbers: LUU 2017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No