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

• Sponsor: Centre Hospitalier Universitaire Dijon (Other)
• Overall Status: Completed
• CT.gov ID: NCT03134495
• Collaborator: (none)
• Enrollment: 290,286
• Location: 1
• Actual Duration (Months): 25
• Patients Per Site Per Month: 11595.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Community Infections	Other: all children with at least one prescription of PPI; Other: all children with no prescription of PPI

Study Design

• Study Type: Observational
• Actual Enrollment: 290286 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: A Cohort Study to Assess the Impact of Paediatric Use of Proton Pump Inhibitors on the Risk of Community Acquired Infections
• Actual Study Start Date: Mar 1, 2015
• Actual Primary Completion Date: Mar 1, 2015
• Actual Study Completion Date: Apr 1, 2017

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. 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

1. Number of specific infections [4 years]

   Comparison of number of infections between PPI exposed and non-exposed

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 11 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

• 1. pylori infection

• Diabetes

• Denutrition

• known digestive upper tract malformation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chu de Dijon	Dijon		France	21079

Sponsors and Collaborators

• Centre Hospitalier Universitaire Dijon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire Dijon
• ClinicalTrials.gov Identifier: NCT03134495
• Other Study ID Numbers: LUU 2017
• First Posted: May 1, 2017
• Last Update Posted: May 1, 2017
• Last Verified: Apr 1, 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Infections; Communicable Diseases; Community-Acquired Infections

Study Results

No Results Posted as of May 1, 2017