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OpenTrials
Completed

NCT Number: NCT03134495

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.

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Key information

Conditions

Community Infections

Age range

Up to 11 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu de Dijon

Dijon, 21079, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

all children with at least one prescription of PPI

Other

all children with at least one prescription of PPI

all children with no prescription of PPI

Other

all children with no prescription of PPI

Primary outcomes

  1. Number of overall infections

    Time frame: 4 years

    Comparison of number of infections between PPI exposed and non-exposed children. All infections are taken in account

Secondary outcomes

  1. Number of specific infections

    Time frame: 4 years

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Official study title

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

Acronym: UTOPIE

Important dates

Study start
2015
Primary completion
2015
Study completion
2017
First posted
May 1, 2017
Registry last updated
May 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.