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Pneumonia Due to Stenotrophomonas Maltophilia in ICUs (RETROSTENO)

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: NCT03506191
Recruitment Status : Unknown
Verified July 2018 by Adrien Bouglé, Groupe Hospitalier Pitie-Salpetriere.
Recruitment status was:  Active, not recruiting
First Posted : April 24, 2018
Last Update Posted : August 1, 2018
Sponsor:
Information provided by (Responsible Party):
Adrien Bouglé, Groupe Hospitalier Pitie-Salpetriere

Brief Summary:

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.


Condition or disease
Pneumonia, Ventilator-Associated Stenotrophomonas Infection Critical Illness Pneumonia, Bacterial

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Pneumonia Due to Stenotrophomonas Maltophilia in Intensive Care Units: a Multicentre Retrospective Study
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : July 30, 2018
Estimated Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Duration of mechanical ventilation [ Time Frame: Day 30 ]
    Number of days under mechanical ventilation

  2. Recurrence of pneumonia due to Stenotrophomonas Maltophilia [ Time Frame: Day 30 ]
    New onset of pneumonia due to Stenotrophomonas Maltophilia

  3. Mortality [ Time Frame: Day 30 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients hospitalized in Intensive Care Unit and presenting pneumonia due to Stenotrophomonas maltophilia
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03506191


Locations
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France
Anesthesiology and Critical Care Medicine, Groupe Hospitalier Pitié-Salpêtrière
Paris, Ile-de-France, France, 75013
Réanimation Polyvalente CHR Metz-Thionville
Metz, France
Department of Anesthesiology and Critical Care Medicine, University Hospital of NANCY
Nancy, France, 54500
Department of Anesthesiology and Critical Care Medicine, University Hospital of Strasbourg
Strasbourg, France
Sponsors and Collaborators
Groupe Hospitalier Pitie-Salpetriere
Investigators
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Study Director: Adrien Bouglé, MD APHP
Principal Investigator: Philippe Guerci, MD CHRU NANCY
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Adrien Bouglé, Study director, Groupe Hospitalier Pitie-Salpetriere
ClinicalTrials.gov Identifier: NCT03506191    
Other Study ID Numbers: RETROSTENO
First Posted: April 24, 2018    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Adrien Bouglé, Groupe Hospitalier Pitie-Salpetriere:
Stenotrophomonas maltophilia
Pneumonia
Intensive Care Unit
Additional relevant MeSH terms:
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Pneumonia, Bacterial
Pneumonia, Ventilator-Associated
Pneumonia
Critical Illness
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes
Bacterial Infections
Cross Infection
Infection