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Tiny bacterial particles linked to lung damage in sepsis patients

NCT ID NCT07686887

Knowledge-focused Sponsor: Southeast University, China Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
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Status unknown
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First seen Jul 07, 2026 · Last updated Jul 14, 2026 · Updated 4 times

Summary

This study investigates whether a particularly dangerous strain of Klebsiella pneumoniae bacteria (hvKP) raises the risk of lung injury in adults with sepsis, compared to a more common strain. Researchers will analyze blood samples for tiny bacterial particles and markers of a specific type of cell death called ferroptosis. The goal is to better understand why some sepsis patients develop acute lung injury, which could lead to earlier detection and better care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could identify early warning signs for lung injury in sepsis patients infected with a dangerous bacteria, potentially guiding future treatments.
What could go wrong
This is an observational study, not a treatment trial. It only looks for links, not causes, and may not lead to any direct medical changes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jul 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Consecutively enrolled adults with clinically suspected sepsis caused by a presumed extra-pulmonary infection will be recruited from emergency departments, hospital wards, and intensive care units. Baseline blood samples will be collected during early sepsis evaluation, before culture results or bacterial molecular typing are available. The primary analytic cohort will include participants who subsequently meet Sepsis-3 criteria, have microbiologically confirmed extra-pulmonary Klebsiella pneumoniae infection, have no acute lung injury at enrollment, and have an available clinical isolate for molecular characterization. Isolates will be classified as hypervirulent Klebsiella pneumoniae, classical Klebsiella pneumoniae, or indeterminate phenotype according to prespecified virulence-gene criteria. Patients with primary pulmonary infection, non-Klebsiella pneumoniae infection, mixed infection, culture-negative sepsis, or non-infectious diagnoses will not enter the primary analysis.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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-related acute lung injury. * Previous enrollment in this study. * Inability to obtain informed consent from the participant or legally authorized representative when deferred-consent procedures are not permitted by the local ethics committee.

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Conditions

The condition(s) this trial relates to.

acute lung injury infectious disease with sepsis Klebsiella infectious disease Klebsiella pneumonia Sepsis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute lung injury(ALI) Hypervirulent klebsiella pneumoniae infection Klebsiella pneumoniae infection Sepsis

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  2. A doctor treating you

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More trials for these conditions

Other studies related to the condition(s) this trial covers.