Children Peritonitis Ecology at CHU de Rennes - (IIAPEDIA) | NCT03668197

Studies
Children Peritonitis Ecology at CHU de Rennes - (IIAPEDIA)

NCT03668197

Sponsor

Rennes University Hospital

Status

Completed

Last Update Posted

Apr 12, 2023Actual

Enrollment

149Actual

Phase

Not provided

Conditions

Peritonitis

Interventions

microbiological analysis

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 2023

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

Nov 23, 2017Actual

Primary Completion Date

Jan 26, 2019Actual

Completion Date

Feb 1, 2019Actual

First Submitted Date

Sep 6, 2018

First Submission Date that Met QC Criteria

Sep 10, 2018

First Posted Date

Sep 12, 2018Actual

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 11, 2023

Last Update Posted Date

Apr 12, 2023Actual

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

The main objectif is assess the germs (species + antibiograms) implicated in children intra-abdominal infections (community acquired or nosocomial ) at CHU de Rennes.

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

149Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
microbiological analysis	Biological	microbiological analysis of the peritoneal fluid

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Blood Culture	Ecology (germs resistance profile)	2 weeks after inclusion

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

No microbiological sampling.
Primitive peritonitis (Spontaneous bacterial peritonitis, peritonitis during peritoneal dialysis)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Children with Intra-abdominal infection and indication for surgery or radiologically guided drainage

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Rennes		Rennes		35033	France

Condition Browse Module

MeSH Terms

ID	Term
D010538	Peritonitis

Ancestor Terms

ID	Term
D059413	Intraabdominal Infections
D007239	Infections
D010532	Peritoneal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided