healthcare-associated pneumonia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients who have at least one of the following backgrounds (i) to (iv), and meet the following (1) to (3): (i) A history of hospitalization within 90 days prior to the onset of pneumonia (ii) Transferred from nursing-care facilities (including those who use psychiatric ward) (iii) Aged patients who need a nursing service(iv)Outpatients who continuously need a intravenus drug therapy (anti-biotics, anti-cancer drug, immunosuprressive drug etc.) (1) Patients with A-DROP moderate bacterial pneumonia (2)Patients who are deemed to be evaluable by a physician in charge (3) Hospitalized patients who are able to submit informed consent and are willing to participate in the study (Informed consent could be acquired from representative)
Exclusion criteria
Exclusion criteria: Apparent massive aspiration (chemical pneumonia due to gastric acid is assumed) Patients with a history of allergy to the study drug or past history of adverse reactions Patients with serious hepatic or renal dysfunction Hepatic dysfunction with AST and ALT elevation at least twice the institutional standard For renal dysfunction at least CKD stage 4 (Japanese Society of Nephrology CKD guideline 2009) Patients with a past history of epilepsy, or those who have central nervous system disease with convulsions at the start of the study Pregnant women, women who are possibly be pregnant, and nursing women Patients with a causative agent not sensitive to the study drug and have been found to be with infection due to strains that are apparently considered not to be sensitive (MRSA, S.maltophilia, legionella group, etc.) Patients who require coadministration of prohibited concomitant drugs Patients with lung cancer who are with apparent causation of airway obstruction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the clinical efficacy among 3 treatment groups at the end of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Life prognosis at 30 days after completion of treatment 2. Ratio of drug-resistant strain of bacteria involvement in HCAP 3. Duration of hospitalization 4. Costs required for antibacterial agents administered until pneumonia was resolved | — |
Countries
Japan
Contacts
Niigata University Medical & Dental Hospital Division of Infection Control and Prevention