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

Community Infections Clinical Trial

— UTOPIE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03134495
• Other study ID #: LUU 2017
• Status: Completed
• Phase: N/A
• First received: April 26, 2017
• Last updated: April 28, 2017
• Start date: March 2015
• Est. completion date: April 2017

Study information

• Verified date: April 2017
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 290286
• Est. completion date: April 2017
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Community Infections
• Community-Acquired Infections
• Infection

Intervention

Other:
• all children with at least one prescription of PPI
all children with at least one prescription of PPI
• all children with no prescription of PPI
all children with no prescription of PPI

Locations

Country	Name	City	State
France	Chu de Dijon	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of specific infections	Comparison of number of infections between PPI exposed and non-exposed	4 years