Not Yet RecruitingNot Applicable

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

120 participantsStarted 2026-07-06

Plain-language summary

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.

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 18-85 years . * Clinical suspicion of infection with acute organ dysfunction consistent with suspected sepsis at the time of enrollment, as determined by the treating clinical team. * Presumed extra-pulmonary source of infection at enrollment, including but not limited to hepatobiliary, urinary, intra-abdominal, skin and soft-tissue, vascular catheter-related, or primary bloodstream infection. * Blood cultures and/or clinically indicated source cultures obtained or ordered as part of routine clinical care. * Enrollment and first research blood collection completed within 6 hours after initiation of the clinical sepsis evaluation. * No evidence of acute lung injury at the index time point, according to the protocol-defined criteria. * Written informed consent obtained from the participant or legally authorized representative, unless an ethics-approved deferred-consent procedure is used. Exclusion Criteria: * Suspected or confirmed primary pulmonary infection at enrollment, including community-acquired pneumonia, hospital-acquired pneumonia, ventilator-associated pneumonia, or aspiration pneumonia. Acute lung injury or acute respiratory distress syndrome present at the index time point. * Acute cardiogenic pulmonary edema, acute decompensated heart failure, or another condition that would preclude reliable adjudication of subsequent non-cardiogenic acute lung injury. * Recent inhalation injury, near-drowning, major thoracic trauma, or transfusion-…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This study is focused on a particularly dangerous strain called hypervirulent Klebsiella pneumoniae — how would my doctor determine whether my infection is actually this hypervirulent type, and does that affect whether this trial would even be relevant to my situation?
2Since this trial is listed as 'not yet recruiting,' how long might it realistically be before it opens, and are there other options — including standard treatments — we should be pursuing in the meantime rather than waiting?
3The trial is observational and is measuring who develops acute lung injury as a new complication of sepsis — does that mean it's a study that watches what happens rather than testing a new treatment, and if so, what would I or my care team actually gain from participating?
4This study is looking at biological markers called outer membrane vesicles and ferroptosis-related signatures — could understanding these markers eventually change how my infection or lung injury is treated, and is that something that might help me directly or only future patients?
5Given that this infection can progress to serious lung injury, what signs should I be watching for that would indicate my condition is worsening, and how does knowing about this research change — if at all — the treatment plan my doctor would recommend right now?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of New-Onset Sepsis-Associated Acute Lung Injury

Timeframe: From enrollment (T0) through Day 7

Trial details

NCT IDNCT07686887

SponsorSoutheast University, China

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2030-07-15

Contact for this trial

Jingyuan Xu, MD

+8613851417209 xujingyuanmail@163.com

View on ClinicalTrials.gov More Sepsis trials