Pneumonia Due to Stenotrophomonas Maltophilia in ICUs

Critical Illness Clinical Trial

— RETROSTENO  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03506191
• Other study ID #: RETROSTENO
• Status: Active, not recruiting
• Start date: January 1, 2017
• Est. completion date: September 30, 2018

Study information

• Verified date: July 2018
• Source: Groupe Hospitalier Pitie-Salpetriere
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: September 30, 2018
• Est. primary completion date: July 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Critical Illness
• Pneumonia
• Pneumonia, Bacterial
• Pneumonia, Ventilator-Associated
• Stenotrophomonas Infection

Locations

Country	Name	City	State
France	Réanimation Polyvalente CHR Metz-Thionville	Metz
France	Department of Anesthesiology and Critical Care Medicine, University Hospital of NANCY	Nancy
France	Anesthesiology and Critical Care Medicine, Groupe Hospitalier Pitié-Salpêtrière	Paris	Ile-de-France
France	Department of Anesthesiology and Critical Care Medicine, University Hospital of Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Pitie-Salpetriere

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment failure	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	Duration of mechanical ventilation	Number of days under mechanical ventilation	Day 30
Secondary	Recurrence of pneumonia due to Stenotrophomonas Maltophilia	New onset of pneumonia due to Stenotrophomonas Maltophilia	Day 30
Secondary	Mortality		Day 30