fever, altered mental status, abdominal pain, chest pain, myalgia
Conditions
Interventions
Case group (severe):NA
Case group (non-severe):None
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18 years or older and provided written informed consent; 2.Patients were required to have clinical manifestations consistent with hvKp infection, supported by microbiological evidence including either: (1) positive culture of sterile body fluids, or (2) detection of Klebsiella pneumoniae along with its virulence factors via mNGS; 3.Enrollment within 48 hours of admission/diagnosis, with the ability to complete baseline sampling and follow-up;
Exclusion criteria
Exclusion criteria: 1.Anticipated survival of less than 24 hours or patients with clinically defined end-stage disease who are not expected to benefit; 2.Pregnancy or breast-feeding; 3.Participation in any other interventional clinical trial within 30 days, or current use of medications that significantly influence the Tryptophan-Kynurenine (Trp-Kyn) pathway (e.g., investigational IDO1 inhibitors); 4.Active malignancy undergoing systemic chemotherapy or immunotherapy; 5.Severe hepatic or renal dysfunction (defined as ALT/AST >5 times the upper limit of normal [ULN], or eGFR <30 mL/min/1.73 m²);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ICU admission within 28 days after hospitalization;The composite endpoint was defined as the need for mechanical ventilation or mortality; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to conversion from positive to negative culture;ICU-free days;28-day all-cause mortality;Length of stay;Peak SOFA score; | — |
Countries
China
Contacts
Public ContactShanshan Jin
Shanghai General Hospital
Outcome results
None listed