Clinical trial NCT05450796: Prognosis and Virulence Determination of Capsule and Endotoxin During Klebsiella Spp. Ventilator-associated Pneumonias
Official title: Prognosis and Virulence Determination of Capsule and Endotoxin During Klebsiella Spp. Ventilator-associated Pneumonias
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ventilator-associated Pneumonia
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2022-07-11
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: - Patient hospitalized in an intensive care unit, with ventilator-associated Klebsiella spp. pneumonia between between July 1, 2022 and July 1, 2024

Brief summary: Ventilator-associated pneumonia is the leading cause of nosocomial infection in the ICU. The pathogens responsible are multiple, but enterobacteria constitute a major source of pathogens involved. Within this family, Klebsiella spp. and Escherichia coli are the two most frequent genera, with Klebsiella spp. often present in severe forms. The factors associated with the occurrence of Ventilator-associated pneumonia and its adverse course depend on host defenses and the virulence of the pathogen. The virulence of Klebsiella spp. depends on several structures, notably the presence of a capsule, the particularities of its lipopolysaccharide, its adhesins (type 3 fimbriae), its capacity to capture iron (siderophores). The objective of this work is to evaluate the role of these different virulence mechanisms in the evolution of Ventilator-associated pneumonia and the hospital prognosis.


Eligibility criteria: Inclusion Criteria:

* Patient whose age is ≥ 18 years
* Patient hospitalized in an intensive care unit
* Patient with ventilator-associated Klebsiella spp. pneumonia
* French-speaking patient

Exclusion Criteria:

* Patient with a severe psychiatric disorder
* Patient under guardianship or curatorship
* Patient deprived of liberty
* Patient under court protection
* Patient who objects to the use of his or her data for this research

Primary outcomes:
measure: Role of 2-hydroxymyristate within lipid A of lipopolysaccharide in the prognosis of mechanically ventilated pneumonia caused by Klebsiella spp.
timeFrame: Month 1
Secondary outcomes:
measure: Effect of other virulence factors on the evolution of ventilator-associated pneumonia
timeFrame: Month 1
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint-Joseph
Study officials:
affiliation: Fondation Hôpital Saint-Joseph
name: François BEAUSSIER, MD
role: PRINCIPAL_INVESTIGATOR
References:
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