NCT03506191

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.

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
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

4 active sites

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

January 1, 2017

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 13, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 24, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

August 1, 2018

Status Verified

July 1, 2018

Enrollment Period

1.6 years

First QC Date

April 13, 2018

Last Update Submit

July 31, 2018

Conditions

Keywords

Stenotrophomonas maltophiliaPneumoniaIntensive Care Unit

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Duration of mechanical ventilation

    Day 30

  • Recurrence of pneumonia due to Stenotrophomonas Maltophilia

    Day 30

  • Mortality

    Day 30

Eligibility Criteria

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

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

You may qualify if:

  • 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).

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Réanimation Polyvalente CHR Metz-Thionville

Metz, France

Location

Department of Anesthesiology and Critical Care Medicine, University Hospital of NANCY

Nancy, 54500, France

Location

Department of Anesthesiology and Critical Care Medicine, University Hospital of Strasbourg

Strasbourg, France

Location

Anesthesiology and Critical Care Medicine, Groupe Hospitalier Pitié-Salpêtrière

Paris, Île-de-France Region, 75013, France

Location

Related Publications (1)

  • Guerci P, Bellut H, Mokhtari M, Gaudefroy J, Mongardon N, Charpentier C, Louis G, Tashk P, Dubost C, Ledochowski S, Kimmoun A, Godet T, Pottecher J, Lalot JM, Novy E, Hajage D, Bougle A; AZUREA research network. Outcomes of Stenotrophomonas maltophilia hospital-acquired pneumonia in intensive care unit: a nationwide retrospective study. Crit Care. 2019 Nov 21;23(1):371. doi: 10.1186/s13054-019-2649-5.

MeSH Terms

Conditions

Pneumonia, Ventilator-AssociatedCritical IllnessPneumonia, BacterialPneumonia

Condition Hierarchy (Ancestors)

Healthcare-Associated PneumoniaCross InfectionInfectionsRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBacterial InfectionsBacterial Infections and Mycoses

Study Officials

  • Adrien Bouglé, MD

    APHP

    STUDY DIRECTOR
  • Philippe Guerci, MD

    CHRU NANCY

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study director

Study Record Dates

First Submitted

April 13, 2018

First Posted

April 24, 2018

Study Start

January 1, 2017

Primary Completion

July 30, 2018

Study Completion

September 30, 2018

Last Updated

August 1, 2018

Record last verified: 2018-07

Locations