Multicentre Observational Study on Community Acquired Int... | NCT03544203

Studies
Multicentre Observational Study on Community Acquired Intraabdominal Infections Management

NCT03544203

Sponsor

Centre Hospitalier Universitaire de Nīmes

Status

Completed

Last Update Posted

Dec 1, 2025Actual

Enrollment

200Actual

Phase

Not provided

Conditions

Intraabdominal Infections

Interventions

Not provided

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

ID	Type	Description	Link
2017-A03407-46	Other Identifier	ANSM

Status Module

Record Verification Date

Jan 2019

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

Apr 1, 2018Actual

Primary Completion Date

Feb 10, 2019Actual

Completion Date

Feb 10, 2019Actual

First Submitted Date

May 22, 2018

First Submission Date that Met QC Criteria

May 22, 2018

First Posted Date

Jun 1, 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

Nov 24, 2025

Last Update Posted Date

Dec 1, 2025Actual

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

Intraabdominal infection require rapid care management including antibiotic therapy and source control. Morbidity and mortality associated with Intraabdominal infections remain high. French recommendations have been edited in 2000 further updated in 2014. Delay in diagnosis and surgery can lead to worsened outcomes. However, little data are available on early community-acquired intraabdominal infections management to identify risk factors of inadequate management.

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

200Actual

Measure	Description	Time Frame
length of stay		6 month

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

≥ 18 years
patients admitted to emergency department for a diagnosis of proven or suspected intraabdominal infection requiring surgery

Exclusion Criteria:

primary intraabdominal infection
health-care associated intraabdominal infection
abdominal trauma
patient under guardianship
opt out consent
patient already enrolled in the present study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients admitted to emergency department for a diagnosis of proven or suspected intraabdominal infection requiring surgery

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU d'Amiens		Amiens	Amiens	80054	France
AP HM La Timone

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35608877	Result	Roger C, Garrigue D, Bouhours G, Dupont H, Bouzat P, Bardon J, Pottecher J, Montravers P, Michelet P, Perbet S, Aymart K, Incagnoli P, Lloret S, Louart B, Harrois A; ACUTE committee. Time to source control and outcome in community-acquired intra-abdominal infections: The multicentre observational PERICOM study. Eur J Anaesthesiol. 2022 Jun 1;39(6):540-548. doi: 10.1097/EJA.0000000000001683.

ID	Term
D059413	Intraabdominal Infections
D010538	Peritonitis
D016638	Critical Illness

ID	Term
D007239	Infections
D010532	Peritoneal Diseases
D004066	Digestive System Diseases
D020969	Disease Attributes