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Early Detection Study of Hypervirulent Klebsiella pneumoniae Infection

Development of a Clinical Early Warning System for Hypervirulent Klebsiella pneumoniae Infections: A Prospective Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500113773
Enrollment
Unknown
Registered
2025-12-03
Start date
2025-12-20
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fever?Disturbance of consciousness?Shock

Interventions

Gold Standard:Klebsiella pneumoniae was identified from a sterile body fluid culture, accompanied by corresponding clinical signs and symptoms of infection.

Sponsors

Shanghai General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age >=18 years; 2.Patients admitted to the Emergency Department or Intensive Care Unit (ICU); 3.Klebsiella pneumoniae detected by metagenomic next-generation sequencing (mNGS); 4.Signed informed consent and agreed to participate in follow-up;

Exclusion criteria

Exclusion criteria: 1.Infections not caused by Klebsiella pneumoniae; 2.Severe immunosuppression (e.g., AIDS, undergoing chemotherapy); 3.Missing key clinical data or loss to follow-u;

Design outcomes

Primary

MeasureTime frame
28-day all-cause mortality;

Secondary

MeasureTime frame
Mechanical ventilation rate;SOFA score;Days of therapy;Length of stay;ICU occupancy rate;

Countries

China

Contacts

Public ContactShanshan Jin

Shanghai General Hospital

018162jss@shgh.cn+86 18217036604

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026