Pneumonia Due to Stenotrophomonas Maltophilia in ICUs

• Conditions: Stenotrophomonas Infection; Pneumonia, Ventilator-Associated; Pneumonia, Bacterial; Critical Illness

• Registration Number: NCT03506191
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2018-04-13
• Study First Submitted QC: 2018-04-21
• Study First Posted: 2018-04-24
• Status Verified: 2018-07
• Primary Completion: 2018-07-30
• Last Update Submitted: 2018-07-31
• Last Update Posted: 2018-08-01
• Study Completion: 2018-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment failure	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

Name	Time	Method
Duration of mechanical ventilation	Day 30	Number of days under mechanical ventilation
Recurrence of pneumonia due to Stenotrophomonas Maltophilia	Day 30	New onset of pneumonia due to Stenotrophomonas Maltophilia
Mortality	Day 30

Trial Locations

Locations (4)

Réanimation Polyvalente CHR Metz-Thionville; 🇫🇷 Metz, France

Department of Anesthesiology and Critical Care Medicine, University Hospital of NANCY; 🇫🇷 Nancy, France

Department of Anesthesiology and Critical Care Medicine, University Hospital of Strasbourg; 🇫🇷 Strasbourg, France

Anesthesiology and Critical Care Medicine, Groupe Hospitalier Pitié-Salpêtrière; 🇫🇷 Paris, Ile-de-France, France