Healthcare associated pneumonia (HCAP) with a pneumonia severity index (PSI) score in risk class III or IV
Conditions
Interventions
Administration of antibiotic (TAZ/PIPC)
Administration of antibiotic (MEPM)
Sponsors
Nagasaki evaluation organization for clinical interventions
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who satisfy the criteria (1) and at least one item of each of (2) and (3). (1) Healthcare associated pneumonia (HCAP) X-ray examination and CT scan of the chest reveal new infiltrative shadows, and one of the following conditions is satisfied. *Patients who were admitted to nursing homes, care/rehabilitation facilities or health/care facilities for recuperation (for more than 48 hours) *Patients who were hospitalized for more than two days for the past 90 days *Patients who receive home fluid therapy *Patients who receive treatment for wounds at home (2) Fever, increased white blood cell count, positive CRP *Fever:37 degrees Celsius and over (axillary temperature) *Increased white blood cell count (WBC>10000/mm3), stab cells>15%, or decreased white blood cell count (WBC<4500/mm3) *Positive CRP (3) Findings of clinical symptoms *Cough *Expectoration of new purulent sputum or secretion from the airways. Aggravation of characteristics of sputum. *Abnormal findings on auscultation and percussion (moist rale, dullness on percussion, decreased breath sounds) *Aggravation of one of the followings: dyspnea, tachypnea, increase in respiratory rate (>30 breaths /min) *Hypoxemia
Exclusion criteria
Exclusion criteria: *Patients with bronchial obstruction or the history of obstructive pneumonia. The patients with COPD, however, are not excluded. *Patients who can not tolerate the administration of selected drug three times a day. *Patients placed on chronic maintenance dialysis *Patients with serious hepatic dysfunction and renal dysfunction(CCr 30 ml/min or under ; -See the separate list of Scr.) *Patients who have difficulty in judgment of the efficacy of selected drug (including patients suffering from cancer or other underlying diseases which prevent the evaluation). *Patients infected probably with MRSA *Patients who are given corticosteroid (prednisolone more than 10 mg/day) *Patients with the history of hypersensitivity to the ingredients of selected drug, penicillin antimicrobials or carbapenem antimicrobials *Pregnant or breastfeeding patients, or patients who have the possibility of being pregnant *Patients with infectious mononucleosis *Patients who were judged as ineligible by their treating physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Judgment of cure A case judged as effective in the evaluation of clinical efficacy at the completion of administration and with no recurrence/flare-up seven days after completion of administration is judged as cured. | — |
Secondary
| Measure | Time frame |
|---|---|
| Judgment of clinical efficacy A case in which the symptoms/findings of pneumonia disappear or are improved and shadows in the lungs or inflammatory findings disappear or are improved is judged as effective. | — |
Countries
Japan
Contacts
Public ContactYoshihiro Yamamoto
Nagasaki University Hospital Second Department of Internal Medicine
Outcome results
None listed