Infectious Mediastinitis Among the Strasbourg Universitary Hospital (MEDIASTINITIS)

November 19, 2021 updated by: University Hospital, Strasbourg, France

Infectious Mediastinitis Among the Strasbourg Universitary Hospital, a Retrospective Cohort

Mediastinitis are rare but serious infections, with mortality rates varying from 6 to 30% according to the literature. They are essentially linked to surgical management (cardio-thoracic in particular), but some forms can be spontaneous, after extension of an ENT infectious focus, for example.

Despite their seriousness, there is no strong recommendations to define their management, especially concerning antibiotic therapy and its duration.

The aim of this research is to make a descriptive analysis of the cases of mediastinitis at HUS in recent years, and to study the therapeutic strategy used

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Strasbourg, France, 67091
        • Recruiting
        • Service de maladies infectieuses et tropicales - Hôpitaux Universitaires de Strasbourg
        • Principal Investigator:
          • Yvon RUCH, MD
        • Contact:
        • Sub-Investigator:
          • Thomas LEMMET, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subject diagnosed with mediastinitis between 01/01/2010 and 31/12/2020

Description

Inclusion Criteria:

  • Major subject (≥18 years old)
  • Subject diagnosed with mediastinitis between 01/01/2010 and 31/12/2020
  • Subject not having expressed his opposition, after information, to the reuse of his data for the purposes of this research.

Exclusion Criteria:

  • Subject having expressed opposition to participate in the study
  • Subject under guardianship, curatorship or safeguard of justice

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Analysis of the cases of mediastinitis and the therapeutic strategy used in recent years at University Hospitals of Strasbourg
Time Frame: Files analysed retrospectively from January 01, 2010 to December 31, 2020 will be examined]
Files analysed retrospectively from January 01, 2010 to December 31, 2020 will be examined]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Investigators

  • Principal Investigator: Yvon RUCH, MD, Service de maladies infectieuses et tropicales - Hôpitaux Universitaires de Strasbourg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Anticipated)

May 1, 2022

Study Completion (Anticipated)

May 31, 2022

Study Registration Dates

First Submitted

August 6, 2021

First Submitted That Met QC Criteria

August 6, 2021

First Posted (Actual)

August 11, 2021

Study Record Updates

Last Update Posted (Actual)

December 2, 2021

Last Update Submitted That Met QC Criteria

November 19, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8262

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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