Ignite Creation Date:
2025-12-24 @ 2:07 PM
Ignite Modification Date:
2026-06-08 @ 4:56 PM
Study NCT ID:
NCT03134495
Status:
COMPLETED
Last Update Posted:
2017-05-01
First Post:
2017-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
the Impact of Paediatric Use of Proton Pump Inhibitors on the Risk of Community Acquired Infections.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 290286}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-28', 'studyFirstSubmitDate': '2017-04-26', 'studyFirstSubmitQcDate': '2017-04-28', 'lastUpdatePostDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of overall infections', 'timeFrame': '4 years', 'description': 'Comparison of number of infections between PPI exposed and non-exposed children. All infections are taken in account'}], 'secondaryOutcomes': [{'measure': 'Number of specific infections', 'timeFrame': '4 years', 'description': 'Comparison of number of infections between PPI exposed and non-exposed'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Community Infections']}, 'descriptionModule': {'briefSummary': '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.\n\nOur 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'all children included in the LDP-CSD database (Cegedim©) aged 11 or below, between 01/01/2008 and 31/12/2013', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged 11 years or below with at least 2 consultations during the follow up\n\nExclusion Criteria:\n\n* chronic pulmonary or cardiac\n* muscoviscidosis\n* immunodeficiency\n* H. pylori infection\n* Diabetes\n* Denutrition\n* known digestive upper tract malformation'}, 'identificationModule': {'nctId': 'NCT03134495', 'acronym': 'UTOPIE', 'briefTitle': 'the Impact of Paediatric Use of Proton Pump Inhibitors on the Risk of Community Acquired Infections.', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Dijon'}, 'officialTitle': 'A Cohort Study to Assess the Impact of Paediatric Use of Proton Pump Inhibitors on the Risk of Community Acquired Infections', 'orgStudyIdInfo': {'id': 'LUU 2017'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PPI exposed children', 'description': 'all children with at least one prescription of PPI', 'interventionNames': ['Other: all children with at least one prescription of PPI']}, {'label': 'non-exposed children', 'description': 'all children with no prescription of PPI', 'interventionNames': ['Other: all children with no prescription of PPI']}], 'interventions': [{'name': 'all children with at least one prescription of PPI', 'type': 'OTHER', 'description': 'all children with at least one prescription of PPI', 'armGroupLabels': ['PPI exposed children']}, {'name': 'all children with no prescription of PPI', 'type': 'OTHER', 'description': 'all children with no prescription of PPI', 'armGroupLabels': ['non-exposed children']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21079', 'city': 'Dijon', 'country': 'France', 'facility': 'Chu de Dijon', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}