community-acquired pneumonia
Conditions
Interventions
treatment group:Administer IVIg at a dose of 0.3g/kg/day for three consecutive days in combination with the standardized treatment protocol for severe pneumonia.
control group:Administer intravenous infusion of placebo (normal saline) for three consecutive days, in addition to the standard treatment protocol for severe pneumonia.
Sponsors
Huashan Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria for This Project: The study cases in this project are patients with a clinical diagnosis of severe community-acquired pneumonia admitted to Huashan Hospital affiliated with Fudan University, using the IDSA/ATS pneumonia severity criteria. Patients who meet these diagnostic criteria are considered to have severe pneumonia. (1) Age =18 years old; (2) Meets the diagnostic criteria for severe pneumonia; (3) Diagnosed with severe pneumonia within 72 hours, including patients whose condition has progressed to severe pneumonia from community-acquired pneumonia with poor response to treatment within 72 hours; (4) The patient or their legal representative has voluntarily signed an informed consent form.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: Patients who meet any of the following criteria should be excluded: (1) Hospital-acquired pneumonia; (2) History of allergy to human immunoglobulin or severe allergic history; (3) Selective IgA deficiency with anti-IgA antibodies; (4) Patients who have received IVIg treatment within 28 days; (5) Lack of signs and laboratory evaluation indicators necessary for infection and clinical assessment, making it impossible to evaluate efficacy and safety; (6) Comorbidities related to IVIg indications, such as primary immunodeficiency disorders affecting antibody production or function, hereditary immunodeficiencies, chronic lymphocytic leukemia, multiple myeloma; neuroimmune diseases, such as chronic inflammatory demyelinating polyneuropathy, multifocal motor neuropathy, Guillain-Barré syndrome, and myasthenia gravis; and autoimmune diseases, such as immune thrombocytopenic purpura, Kawasaki disease; (7) Participation in other clinical interventional studies within the last 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause mortality at 7 days; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinically effective rate;Safety; | — |
Countries
China
Contacts
Public ContactChunlai Ma
Huashan Hospital Affiliated to Fudan University
Outcome results
None listed