Pneumonia Due to Stenotrophomonas Maltophilia in ICUs (RETROSTENO)

July 31, 2018 updated by: Adrien Bouglé, Groupe Hospitalier Pitie-Salpetriere

Pneumonia Due to Stenotrophomonas Maltophilia in Intensive Care Units: a Multicentre Retrospective Study

Pneumonia is a major cause of ICU admission, or may complicate ICU course. Among the causative pathogens, Stenotrophomonas Maltophilia is a rare pathogen, but affects usually patients with chronic pulmonary co-morbidities, or with long duration of mechanical ventilation and multiples treatment with broad spectrum antimicrobial therapy. However, there are only a paucity of data regarding epidemiology, impact and outcome of Pneumonia due to Stenotrophomonas Maltophilia in critically ill patients.

Primary objective was to study factors associated with mortality in case of Pneumonia due to Stenotrophomonas Maltophilia. Secondary objectives were to describe factors associated with morbidity of Pneumonia due to Stenotrophomonas Maltophilia (duration of mechanical ventilation, ICU length of stay), and to report the characteristics of critically ill patients presenting Pneumonia due to Stenotrophomonas Maltophilia.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

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

Study Locations

  • France
      • Metz, France
        • Réanimation Polyvalente CHR Metz-Thionville
      • Nancy, France, 54500
        • Department of Anesthesiology and Critical Care Medicine, University Hospital of NANCY
      • Strasbourg, France
        • Department of Anesthesiology and Critical Care Medicine, University Hospital of Strasbourg
    • Ile-de-France
      • Paris, Ile-de-France, France, 75013
        • Anesthesiology and Critical Care Medicine, Groupe Hospitalier Pitié-Salpêtrière

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

Patients hospitalized in Intensive Care Unit and presenting pneumonia due to Stenotrophomonas maltophilia

Description

Inclusion Criteria:

Patients older than 18 years

Documented Stenotrophomonas maltophilia pneumonia:

  • Clinical suspicion (≥ two criteria including: fever> 38.5°C, leukocytosis > 10^9/L or leukopenia < 4.10^8/L, purulent tracheobronchial secretions and a new or persistent infiltrate on chest radiography).
  • Documented Stenotrophomonas maltophilia positive quantitative culture of a respiratory sample: bronchoalveolar lavage fluid (significant threshold, >10^4cfu/ml) or plugged telescopic catheter (significant threshold, >10^3cfu/ml) or quantitative endotracheal aspirate (significant threshold, >10^6cfu/ml).

Exclusion Criteria:

  • None

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: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment failure
Time Frame: Day 30
Treatment failure is defined as composite of death and recurrence of pneumonia due to Stenotrophomonas Maltophilia within 30 days of the first episode
Day 30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: Day 30
Day 30
Duration of mechanical ventilation
Time Frame: Day 30
Number of days under mechanical ventilation
Day 30
Recurrence of pneumonia due to Stenotrophomonas Maltophilia
Time Frame: Day 30
New onset of pneumonia due to Stenotrophomonas Maltophilia
Day 30

Collaborators and Investigators

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

Sponsor

Groupe Hospitalier Pitie-Salpetriere

Investigators

  • Study Director: Adrien Bouglé, MD, APHP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 1, 2017

Primary Completion (Actual)

July 30, 2018

Study Completion (Anticipated)

September 30, 2018

Study Registration Dates

First Submitted

April 13, 2018

First Submitted That Met QC Criteria

April 21, 2018

First Posted (Actual)

April 24, 2018

Study Record Updates

Last Update Posted (Actual)

August 1, 2018

Last Update Submitted That Met QC Criteria

July 31, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RETROSTENO

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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