Nosocomial pneumonia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients with nosocomial pneumonia: 16-year old or older patients with pneumonia which appeared newly more than 48 hours after hospitalization (including aspiration pneumonia and ventilator-associated pneumonia)* *[Diagnosis of nosocomial pneumonia] Patients showing clinical symptoms such as coughing, expectoration, fever, etc., and a shadow of infiltration considered to appear newly in the imaging diagnosis such as thoracic X-ray or CT, etc.
Exclusion criteria
Exclusion criteria: (1) Patients with a history of hypersensitivity to the ingredients of this product, such as shock (2) Children (younger than 16 years old) (3) Patients with infectious mononucleosis (4) Patients receiving sodium valproate (5) Pregnant women, lactating women, or patients possibly to be pregnant (6) Patients with hepatic, renal or cardiac diseases, immunodeficiency, other serious underlying diseases or complications, who have difficulty in evaluation of the efficacy of this product. (7) Patients in the group with severe disease (C group), for whom combination with antimicrobial agents is recommended in the guidelines for treatment of nosocomial pneumonia of the Japanese Respiratory Society (8) Other patients judged to be unsuitable as subjects by the physicians in charge
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical effect (efficacy ratio) at the end or discontinuation of administration | — |
Countries
Japan
Contacts
Aichi Medical University Hospital Department of Infection Control and Prevention