NCT05001308

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 11, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
Last Updated

December 2, 2021

Status Verified

August 1, 2021

Enrollment Period

11 months

First QC Date

August 6, 2021

Last Update Submit

November 19, 2021

Conditions

Keywords

MediastinitisSternitisDeep Sternal Wound Infection

Outcome Measures

Primary Outcomes (1)

  • Analysis of the cases of mediastinitis and the therapeutic strategy used in recent years at University Hospitals of Strasbourg

    Files analysed retrospectively from January 01, 2010 to December 31, 2020 will be examined]

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de maladies infectieuses et tropicales - Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Mediastinitis

Condition Hierarchy (Ancestors)

Mediastinal DiseasesThoracic DiseasesRespiratory Tract Diseases

Study Officials

  • Yvon RUCH, MD

    Service de maladies infectieuses et tropicales - Hôpitaux Universitaires de Strasbourg

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2021

First Posted

August 11, 2021

Study Start

June 1, 2021

Primary Completion

May 1, 2022

Study Completion

May 31, 2022

Last Updated

December 2, 2021

Record last verified: 2021-08

Locations