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Multicentre Observational Study on Community Acquired Intraabdominal Infections Management (PERICOM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03544203
Recruitment Status : Completed
First Posted : June 1, 2018
Last Update Posted : May 3, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

Tracking Information
First Submitted Date May 22, 2018
First Posted Date June 1, 2018
Last Update Posted Date May 3, 2019
Actual Study Start Date April 1, 2018
Actual Primary Completion Date February 28, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 22, 2018)
length of stay [ Time Frame: 6 month ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Multicentre Observational Study on Community Acquired Intraabdominal Infections Management
Official Title Multicentre Observational Study on Community Acquired Intraabdominal Infections Management: the PERICOM Study
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
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population patients admitted to emergency department for a diagnosis of proven or suspected intraabdominal infection requiring surgery
Condition Intraabdominal Infections
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 22, 2018)
200
Original Estimated Enrollment Same as current
Actual Study Completion Date March 30, 2019
Actual Primary Completion Date February 28, 2019   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03544203
Other Study ID Numbers 2017-A03407-46
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Centre Hospitalier Universitaire de Nīmes
Study Sponsor Centre Hospitalier Universitaire de Nīmes
Collaborators Not Provided
Investigators Not Provided
PRS Account Centre Hospitalier Universitaire de Nīmes
Verification Date January 2019