PROVIDENCE: Prognosis and Virulence Determination of Capsule and Endotoxin During Klebsiella Spp. Ventilator-associated Pneumonias

Sponsor
Groupe Hospitalier Paris Saint Joseph (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05450796
Collaborator
(none)
1,000
1
27.5
36.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Prognosis and Virulence Determination of Capsule and Endotoxin During Klebsiella Spp. Ventilator-associated Pneumonias
    Anticipated Study Start Date :
    Sep 15, 2022
    Anticipated Primary Completion Date :
    Sep 15, 2024
    Anticipated Study Completion Date :
    Dec 31, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Role of 2-hydroxymyristate within lipid A of lipopolysaccharide in the prognosis of mechanically ventilated pneumonia caused by Klebsiella spp. [Month 1]

      This outcome corresponds to the prognostic value (prediction of clinical cure) of the studied virulence parameters (myristate hydroxylation, presence of fimbriae, expression of siderophores, expression of capsule) at D7 of effective antibiotic treatment, according to the virulence parameters of the pathogen, after adjustment on known prognostic factors. This value will be estimated by the adjusted HR, the improvement of the model fit, the number of patients who change classification (cured/not cured) after inclusion of this factor.

    Secondary Outcome Measures

    1. Effect of other virulence factors on the evolution of ventilator-associated pneumonia [Month 1]

      This outcome corresponds to the prognostic value (accuracy of recurrence of pulmonary infection under mechanical ventilation with the same germ (Klebsiella spp.) during the stay in intensive care.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Groupe Hospitalier Paris Saint-Joseph Paris France 75014

    Sponsors and Collaborators

    • Groupe Hospitalier Paris Saint Joseph

    Investigators

    • Principal Investigator: François BEAUSSIER, MD, Groupe Hospitalier Paris Saint Joseph

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Groupe Hospitalier Paris Saint Joseph
    ClinicalTrials.gov Identifier:
    NCT05450796
    Other Study ID Numbers:
    • PROVIDENCE
    First Posted:
    Jul 11, 2022
    Last Update Posted:
    Aug 3, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 3, 2022