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

NCT ID: NCT03134495

Last Updated: 2017-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

290286 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-31

Study Completion Date

2017-04-30

Brief Summary

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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

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Conditions

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Community Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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PPI exposed children

all children with at least one prescription of PPI

all children with at least one prescription of PPI

Intervention Type OTHER

all children with at least one prescription of PPI

non-exposed children

all children with no prescription of PPI

all children with no prescription of PPI

Intervention Type OTHER

all children with no prescription of PPI

Interventions

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all children with at least one prescription of PPI

all children with at least one prescription of PPI

Intervention Type OTHER

all children with no prescription of PPI

all children with no prescription of PPI

Intervention Type OTHER

Eligibility Criteria

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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
Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chu de Dijon

Dijon, , France

Site Status

Countries

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France

Other Identifiers

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LUU 2017

Identifier Type: -

Identifier Source: org_study_id

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