Comparative Study of Usefulness of TAZ/PIPC and MEPM in Healthcare Associated Pneumonia (HCAP): Survey on the Actual Condition of Healthcare Associated Pneumonia (HCAP) in Japan

UMIN ID: UMIN000002269

Registered date:01/08/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Healthcare associated pneumonia (HCAP) with a pneumonia severity index (PSI) score in risk class III or IV
• Date of first enrollment: 2009/08/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Administration of antibiotic (TAZ/PIPC)
Administration of antibiotic (MEPM)

Outcome(s)

• Primary Outcome: 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 Outcome: 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.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Nagasaki evaluation organization for clinical interventions
• Source(s) of Monetary Support: Nagasaki evaluation organization for clinical interventions