Community-acquired pneumonia (CAP), hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP), coronavirus disease 2019 (COVID-19), and sepsis
Conditions
Interventions
None listed
Sponsors
Nagoya University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with pneumonia or sepsis. - Pneumonia is defined as the presence of a new infiltrate on a chest X-ray, or a computed tomography scan, plus at least one of the following criteria: 1) cough or purulent sputum, 2) pleuritic chest pain, 3) dyspnea, 4) fever or hypothermia (temperature >= 37.5 degrees or < 35 degrees), 5) white blood cell count >= 10,000 /mm3 or < 4,000 /mm3, 6) increase of CRP or PCT values above the upper limit of facility reference value and 7) hypoxemia (SpO2 < 90% or PaO2 < 60 Torr) or decline in oxygenation. - COVID-19 is confirmed by a positive polymerase-chain-reaction test or antigen test. - Sepsis is defined as the presence of a clear infection or suspected infection with the Sequential Organ Failure Assessment (SOFA) score of 2 points or more increase from the baseline score (if the baseline SOFA score before the onset of sepsis is unknown and presumed to be free of organ damage, the baseline SOFA score is considered to be 0).
Exclusion criteria
Exclusion criteria: 1) Patients who do not receive initial empirical antibiotic treatment 2) Patients with obstructive pneumonia 3) Pneumonia or sepsis occurred in other hospitals and patients who were transferred from other hospitals with a trend toward improvement 4) Patients whose pneumonia or sepsis recurred within 3 days after the last day of antibiotic treatment of a preceding pneumonia or sepsis episode 5) Patients who receive the treatment in outpatient clinics 6) Patients who were enrolled in this study previously 7) Patients over 90 years old 8) HIV positive patients 9) Pregnant women 10) Patients with neutropenia (neutrophil counts <1,000/mm3) 11) Patients with active hematologic malignancies 12) Patients after blood stem cell transplants, including bone marrow transplants 13) Patients treated for co-morbidities with high-dose glucocorticoid
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Clinical outcomes Death, progression to severe state, secondary adverse events, and treatment failure 2) Immunological outcome Association between host immune characteristics and clinical outcomes | — |
Countries
Japan
Contacts
Public ContactYuichiro Shindo
Nagoya University Hospital Respiratory Medicine
Outcome results
None listed