PeritonitisIIAPEDIANCT03668197
Children Peritonitis Ecology at CHU de Rennes - (IIAPEDIA)
An observational study of Peritonitis, run by Rennes University Hospital at 1 site in France.
Trial summary
The main objectif is assess the germs (species + antibiograms) implicated in children intra-abdominal infections (community acquired or nosocomial ) at CHU de Rennes. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Peritonitis
- What is being tested?
- microbiological analysis
- How many people
- 149 participants
- Where
- 1 siteFrance
- Study dates
- 23 Nov 2017to 1 Feb 2019
- 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 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with Intra-abdominal infection and indication for surgery or radiologically guided drainage
Who may be able to join
- Children between 0 and 18 years old
- Intra-abdominal infection with and indication for surgery or radiologically guided drainage.
- No opposition from the child or his parents
Who cannot join
- No microbiological sampling.
- Primitive peritonitis (Spontaneous bacterial peritonitis, peritonitis during peritoneal dialysis)
Trial locations and contacts
1 site in 1 country.
About this study
The main objectif is assess the germs (species + antibiograms) implicated in children intra-abdominal infections (community acquired or nosocomial ) at CHU de Rennes.
- Conditions
- Peritonitis
- Being tested
- microbiological analysis
- Medical subject headings
- Peritonitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microbiological analysisBiological
microbiological analysis of the peritoneal fluid
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Culture
Ecology (germs resistance profile)
Measured: 2 weeks after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start23 Nov 2017
- Primary completion26 Jan 2019
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeritonitisStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Prospective
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03668197
- Sponsor's protocol ID
- 35RC17_3086_IIAPEDIA
- Acronym
- IIAPEDIA
- Status last verified
- Apr 2023
- First submitted
- 6 Sep 2018
- Last updated
- 12 Apr 2023
- 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 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Children Peritonitis Ecology at CHU de Rennes - (IIAPEDIA)
- ClinicalTrials.gov ID
- NCT03668197
- Acronym / sponsor ID
- IIAPEDIA / 35RC17_3086_IIAPEDIA
- Conditions
- Peritonitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 23 Nov 2017 (actual)
- Primary completion
- 26 Jan 2019 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 12 Sep 2018 (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.
The main objectif is assess the germs (species + antibiograms) implicated in children intra-abdominal infections (community acquired or nosocomial ) at CHU de Rennes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with Intra-abdominal infection and indication for surgery or radiologically guided drainage
Key inclusion criteria (3 listed)
- Children between 0 and 18 years old
- Intra-abdominal infection with and indication for surgery or radiologically guided drainage.
- No opposition from the child or his parents
Key exclusion criteria (2 listed)
- No microbiological sampling.
- Primitive peritonitis (Spontaneous bacterial peritonitis, peritonitis during peritoneal dialysis)
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 |
|---|---|---|
| microbiological analysismicrobiological analysis of the peritoneal fluid | Biological | – |
Primary outcome
Blood Culture
Time frame: 2 weeks after inclusion
Ecology (germs resistance profile)
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 12 Apr 2023.
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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 Peritonitis, run by Rennes University Hospital 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 3 inclusion and 2 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 12 Apr 2023. 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?
Blood Culture (time frame: 2 weeks after inclusion). 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 12 Apr 2023.