An observational study in Sepsis, Acute Lung Injury(ALI) and Klebsiella Pneumoniae Infection, sponsored by Southeast University, China. Not yet recruiting. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-07-13.
Sponsored by Southeast University, China · Observational
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Among 21 studies in Sepsis by Southeast University, China — 7 open to participants now, 8 under way, 1 of them phase 3. Sepsis · Southeast University, China.
Among the 21 studies in Sepsis by Southeast University, China, this one is one of 3 that started in 2026, is one of 9 observational ones, and was the 20th registered.
2,417 studies on the registry are indexed under Sepsis; 542 are open to participants now.
Browse Sepsis studies →7 of the 21 studies in Sepsis by Southeast University, China are open now, in 1 country. Recruiting first, the newest first:
Southeast University, China · Sites in China
Southeast University, China · Sites in China
Ages 18–85
Southeast University, China · Sites in China
Ages 18+
Southeast University, China · Sites in China
Ages 18+
Southeast University, China
Ages 18–75 · Healthy volunteers
By country, each count listing its studies:
Of the 318 Sepsis studies recruiting now, 213 (67%) set no upper age limit and 53 (17%) stop at 75 or younger; 68 take children under 18; 42 take healthy volunteers.
This study: 18 Years to 85 Years · all sexes · no healthy volunteers.
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21 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 1 · Phase 3 2 · Phase 4 4
First in 2011; this study’s year is marked. 3 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 120 is below the median of 150 across 1,162 observational studies indexed under Sepsis.
Median enrollment 80 across the 12 interventional studies, 120 across the 9 observational. Of the 7 that completed or were terminated, 0 (0%) have results posted.
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Southeast University, China is the lead sponsor of 168 studies on the registry; 45 are open to participants now.
1 of the studies in Sepsis by Southeast University, China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07922954Southeast University, ChinaThymosin Alpha 1 and IgM Levels in Sepsis | 2027-01-31 |
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Among the 21 studies in Sepsis by Southeast University, China, from their registry updates:
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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.
Sepsis-associated acute lung injury is a major complication of severe extra-pulmonary Gram-negative bacterial infection. Hypervirulent Klebsiella pneumoniae (hvKP) is increasingly recognized as a cause of invasive infection with a high inflammatory burden and a propensity for metastatic spread. Bacterial outer membrane vesicles (OMVs) are biologically active nanoparticles that may transport lipopolysaccharide, virulence-associated molecules, and other inflammatory cargo to distant organs. Experimental evidence suggests that OMV-mediated oxidative stress and ferroptosis-related injury may contribute to pulmonary endothelial dysfunction and acute lung injury; however, the clinical relevance of these mechanisms in patients with extra-pulmonary hvKP sepsis remains unclear.
This prospective multicenter observational translational cohort study will investigate the relationship among molecularly characterized hvKP infection, circulating bacterial OMV-related signals, ferroptosis-related biomarker profiles, and the subsequent development of sepsis-associated acute lung injury. Adults with microbiologically confirmed extra-pulmonary Klebsiella pneumoniae sepsis will be enrolled early after sepsis recognition and followed during the acute phase of illness. Clinical isolates will undergo molecular characterization for prespecified hypervirulence-associated genes and additional strain-level features. Blood specimens collected during routine early follow-up will be processed using standardized procedures for plasma, serum, and peripheral blood mononuclear cell analyses.
The laboratory component will quantify circulating Gram-negative bacterial OMV-related signals in platelet-depleted plasma and evaluate systemic ferroptosis-related biomarker profiles, including lipid peroxidation products, glutathione redox status, iron-related indices, and ferroptosis-associated gene expression. Patient-derived Klebsiella pneumoniae isolates will also be cultured under standardized conditions for OMV isolation and characterization.
A nested translational substudy will compare OMVs derived from representative hvKP and classical Klebsiella pneumoniae isolates. Equal-particle-number OMV preparations will be applied to human pulmonary microvascular endothelial cells to assess lipid peroxidation, ferroptosis-related molecular changes, endothelial barrier integrity, and the in vitro rescue effect of Ferrostatin-1. No investigational intervention will be administered to study participants, and all clinical management will remain at the discretion of the treating physicians.
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.
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Exclusion Criteria:
Acute lung injury or acute respiratory distress syndrome present at the index time point.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cohort 1 Description: Participants with subsequently confirmed extra-pulmonary Klebsiella pneumoniae infection whose clinical isolate carries iucA, iroB, peg-344, rmpA, and rmpA2.
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.
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.
Incidence of New-Onset Sepsis-Associated Acute Lung Injury
New-onset sepsis-associated acute lung injury occurring after enrollment and within 7 days, defined by acute respiratory deterioration, new bilateral pulmonary opacities, hypoxemia, and respiratory failure not fully explained by cardiac failure or fluid overload. Acute lung injury will be adjudicated independently by two physicians blinded to bacterial molecular classification and biomarker results.
Time frame: From enrollment (T0) through Day 7
Circulating Gram-Negative Bacterial Outer Membrane Vesicle-Related Signal
Standardized level of lipopolysaccharide-positive extracellular nanoparticles in platelet-depleted plasma, measured using nano-flow cytometry or an equivalent validated assay. The result will be interpreted as a Gram-negative bacterial outer membrane vesicle-related signal.
Time frame: At enrollment (T0), 24 hours, and 72 hours after enrollment
Ferroptosis-Related Biomarker Profile
Systemic ferroptosis-related biomarker profile assessed by plasma 4-hydroxynonenal protein adducts, malondialdehyde, glutathione, glutathione disulfide, glutathione/glutathione disulfide ratio, iron-related indices, and peripheral blood mononuclear cell expression of GPX4, SLC7A11, ACSL4, FTH1, and NCOA4.
Time frame: At enrollment (T0), 24 hours, and 72 hours after enrollment
Lowest PaO₂/FiO₂ Ratio (or SpO₂/FiO₂ Ratio)
Respiratory dysfunction assessed by the lowest PaO₂/FiO₂ ratio during the observation period. If arterial blood gas analysis is unavailable, the lowest SpO₂/FiO₂ ratio will be used.
Time frame: From enrollment through Day 7
Respiratory Sequential Organ Failure Assessment (SOFA) Score
Respiratory dysfunction assessed by the respiratory component of the SOFA score. The Respiratory SOFA sub-score ranges from 0 to 4, on an integer scale, with higher scores indicating worse respiratory function . The score is derived daily from the lowest PaO₂/FiO₂ ratio (or SpO₂/FiO₂ imputation) and the requirement for mechanical ventilation.
Time frame: From enrollment through Day 7
Ventilator-Free Days
Number of days alive and free from invasive mechanical ventilation during the first 28 days after enrollment. Participants who die before Day 28 will be assigned zero ventilator-free days.
Time frame: From enrollment through Day 28
All-Cause Mortality
Death from any cause after enrollment.
Time frame: From enrollment through Day 28
No study locations are listed for this record.
Plan to share: Undecided — The decision regarding sharing of de-identified individual participant data has not yet been finalized. The research team will evaluate data-sharing feasibility after study completion, taking into account participant privacy, informed consent, institutional ethics requirements, data protection regulations, and the sensitivity of clinical and microbiological data.
Start is estimated for Jul 2026; primary completion for Jul 2030, 48 months later.
Of 492 non-industry observational studies under Sepsis, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 58. This study's planned 48 months is above that.
Counting every sponsor, half of 544 studies reached it within 27 months; a quarter within 12 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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