Outer Membrane Vesicle and Ferroptosis-Related Signatures in Sepsis-Associated Acute Lung Injury Caused by Extra-Pulmonary Hypervirulent Klebsiella Pneumoniae

Sponsor
Southeast University, China
Study ID
NCT07686887
Status
Not Yet Recruiting

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Conditions

  • Acute Lung Injury(ALI)
  • Hypervirulent Klebsiella Pneumoniae Infection
  • Klebsiella Pneumoniae Infection
  • Sepsis

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Study Details

This prospective observational translational cohort study will investigate whether extra-pulmonary infection caused by hypervirulent Klebsiella pneumoniae (hvKP) is associated with an increased risk of sepsis-associated acute lung injury (SALI), compared with infection caused by classical Klebsiella pneumoniae (cKP). The study will further examine whether circulating bacterial outer membrane vesicle (OMV) signals and ferroptosis-related biomarker profiles are associated with subsequent SALI development. Adults with Sepsis-3 and microbiologically confirmed extra-pulmonary K. pneumoniae infection will be enrolled within 6 hours of sepsis recognition. Patients with acute lung injury at enrollment will be excluded from the primary cohort. Blood samples will be collected at enrollment, 24 hours, and 72 hours. Clinical isolates will undergo molecular characterization to classify infections as hvKP or cKP. The primary outcome will be new-onset SALI within 7 days after enrollment. A nested translational substudy will evaluate the effects of patient-isolate-derived OMVs on human pulmonary microvascular endothelial cells. The study will not alter antimicrobial therapy, source control, respiratory support, fluid management, or any other aspect of routine clinical care.

Key Dates

First listed
Jul 7, 2026
Start date
Jul 6, 2026
Status verified
Jul 2026
Primary completion
Jul 15, 2030
Completion
Jul 30, 2030

Study Design

Enrollment
120 participants (estimated)

Arms

  • Arm: Cohort 1 Title: Hypervirulent Klebsiella pneumoniae Infection
    Cohort 1 Description: Participants with subsequently confirmed extra-pulmonary Klebsiella pneumoniae infection whose clinical isolate carries iucA, iroB, peg-344, rmpA, and rmpA2.
  • Arm: Cohort 2 Title: Classical Klebsiella pneumoniae Infection
    Cohort 2 Description: Participants with subsequently confirmed extra-pulmonary Klebsiella pneumoniae infection whose clinical isolate lacks all five prespecified hypervirulence-associated genes: iucA, iroB, peg-344, rmpA, and rmpA2.
  • Arm: Cohort 3 Title: Indeterminate Klebsiella pneumoniae Molecular Phenotype
    Cohort 3 Description: Participants with subsequently confirmed extra-pulmonary Klebsiella pneumoniae infection whose clinical isolate carries one to four of the five prespecified hypervirulence-associated genes. This cohort will be included in exploratory analyses only.

Primary Outcome Measure

Incidence of New-Onset Sepsis-Associated Acute Lung Injury [ Time Frame: From enrollment (T0) through Day 7 ]

Central Contacts

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