the Impact of Paediatric Use of Proton Pump Inhibitors on... | NCT03134495

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

NCT03134495

Sponsor

Centre Hospitalier Universitaire Dijon

Status

Completed

Last Update Posted

May 1, 2017Actual

Enrollment

290,286Actual

Phase

Not provided

Conditions

Community Infections

Interventions

all children with at least one prescription of PPI
all children with no prescription of PPI

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2015Actual

Primary Completion Date

Mar 2015Actual

Completion Date

Apr 2017Actual

First Submitted Date

Apr 26, 2017

First Submission Date that Met QC Criteria

Apr 28, 2017

First Posted Date

May 1, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 28, 2017

Last Update Posted Date

May 1, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

290,286Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PPI exposed children		all children with at least one prescription of PPI	Other: 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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
all children with at least one prescription of PPI	Other	all children with at least one prescription of PPI	PPI exposed children

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
Number of specific infections	Comparison of number of infections between PPI exposed and non-exposed	4 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

11 Years

Standard Ages

Child

Study Population

Sampling Method

Non-Probability Sample