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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05450796
Acronym
PROVIDENCE
Enrollment
1000
Registered
2022-07-11
Start date
2022-06-17
Completion date
2024-12-31
Last updated
2022-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventilator-associated Pneumonia

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.

Interventions

None listed

Sponsors

Fondation Hôpital Saint-Joseph
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

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

MeasureTime frameDescription
Effect of other virulence factors on the evolution of ventilator-associated pneumoniaMonth 1This 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.

Countries

France

Contacts

Primary ContactFrançois PHILIPPART, MD
fphilippart@ghpsj.fr144127021
Backup ContactHelene BEAUSSIER, PharmD, PhD
crc@ghpsj.fr144127883

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026