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

Completed

• Conditions: Community Infections
• Interventions: Other: all children with no prescription of PPI; Other: all children with at least one prescription of PPI

• Registration Number: NCT03134495
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Primary Completion: 2015-03
• Status Verified: 2017-04
• Study Completion: 2017-04
• Study First Submitted: 2017-04-26
• Study First Submitted QC: 2017-04-28
• Last Update Submitted: 2017-04-28
• Study First Posted: 2017-05-01
• Last Update Posted: 2017-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 290286

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
non-exposed children	all children with no prescription of PPI	all children with no prescription of PPI
PPI exposed children	all children with at least one prescription of PPI	all children with at least one prescription of PPI

Primary Outcome Measures

Name	Time	Method
Number of overall infections	4 years	Comparison of number of infections between PPI exposed and non-exposed children. All infections are taken in account

Secondary Outcome Measures

Name	Time	Method
Number of specific infections	4 years	Comparison of number of infections between PPI exposed and non-exposed

Trial Locations

Locations (1)

Chu de Dijon; 🇫🇷 Dijon, France