Community InfectionsUTOPIENCT03134495
the Impact of Paediatric Use of Proton Pump Inhibitors on the Risk of Community Acquired Infections.
An observational study of Community Infections, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages Up to 11 years
- Conditions the study is for
- Community Infections
- What is being tested?
- all children with at least one prescription of PPI and all children with no prescription of PPI
- How many people
- 290,286 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2015to Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 11 years
- All sexes
- No healthy volunteers
- Child
Study population: all children included in the LDP-CSD database (Cegedim©) aged 11 or below, between 01/01/2008 and 31/12/2013
Who may be able to join
- Children aged 11 years or below with at least 2 consultations during the follow up
Who cannot join
- chronic pulmonary or cardiac
- muscoviscidosis
- immunodeficiency
- H. pylori infection
- Diabetes
- Denutrition
- known digestive upper tract malformation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Cohort Study to Assess 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.
- Conditions
- Community Infections
- Being tested
- all children with at least one prescription of PPI, all children with no prescription of PPI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
all children with at least one prescription of PPIOther
all children with at least one prescription of PPI
all children with no prescription of PPIOther
all children with no prescription of PPI
| Study group | Role | What they receive |
|---|---|---|
| PPI exposed children | all children with at least one prescription of PPI Receives: Other: all children with at least one prescription of PPI | |
| non-exposed children | all children with no prescription of PPI Receives: Other: all children with no prescription of PPI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of overall infections
Comparison of number of infections between PPI exposed and non-exposed children. All infections are taken in account
Measured: 4 years
Secondary outcomes (1)
Number of specific infections
Comparison of number of infections between PPI exposed and non-exposed
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2017
- Study startMar 2015
- Primary completionMar 2015
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community InfectionsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 290,286 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03134495
- Sponsor's protocol ID
- LUU 2017
- Acronym
- UTOPIE
- Status last verified
- Apr 2017
- First submitted
- 26 Apr 2017
- Last updated
- 1 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Study to Assess the Impact of Paediatric Use of Proton Pump Inhibitors on the Risk of Community Acquired Infections
- ClinicalTrials.gov ID
- NCT03134495
- Acronym / sponsor ID
- UTOPIE / LUU 2017
- Conditions
- Community Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 290,286 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- Mar 2015 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 1 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PPI exposed children | – | Other: all children with at least one prescription of PPIall children with at least one prescription of PPI |
| non-exposed children | – | Other: all children with no prescription of PPIall children with no prescription of PPI |
Who may qualify
- Ages
- Up to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- all children included in the LDP-CSD database (Cegedim©) aged 11 or below, between 01/01/2008 and 31/12/2013
Key inclusion criteria (1 listed)
- Children aged 11 years or below with at least 2 consultations during the follow up
Key exclusion criteria (7 listed)
- chronic pulmonary or cardiac
- muscoviscidosis
- immunodeficiency
- H. pylori infection
- Diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| all children with at least one prescription of PPIall children with at least one prescription of PPI | Other | PPI exposed children |
| all children with no prescription of PPIall children with no prescription of PPI | Other | non-exposed children |
Primary outcome
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
1 secondary outcome
Number of specific infections
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Community Infections, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of overall infections (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2017.