Clinical evaluation of Biapenem 0.3g, three times daily dosing in eldery patients with pneumonia (moderate and severe infection)

UMIN ID: UMIN000003964

Registered date:29/07/2010

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Moderate and severe pneumonia
• Date of first enrollment: 2010/07/01
• Target sample size: 50
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Elderly patients (50 cases) aged 65 and over with moderate and severe pneumonia, treated with Biapenem 0.3g three times daily for less than 2 weeks during the period of July 2010 to May 2011

Outcome(s)

• Primary Outcome: Evaluation of clinical response after 3 days administration, clinical response at the end of treatment, bacteriological response, serum concentration measurement and PK-PD analysis

Key inclusion & exclusion criteria

• Age minimum: 65years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: (1)Cases with severe cardiac, hepatic, renal function disorder(2)Cases with a history of allergy to B-lactam antibiotics(carbapenems,cephems,penicillins,etc.)(3)Cases which therapeutic response of B-lactam antibiotics can't be expected(caused by virus,mycoplasma,chlamydia and fungus)(4)Cases treated with sodium valproate(5)Cases with improvement by previous treatment of antimicrobial agent(6)Cases with similar infectious episode of ineffective treatment with carbapenem antibiotics(7)Other cases which doctor in charge regard inadequate to include in the study

Related Information

• Primary Sponsor: Fuji Heavy Industries Ltd Health Insurance Society Ota Hospital: Neurology, Ashikaga Red Cross Hospital :Respiratory internal medicine
• Source(s) of Monetary Support: Keio University Faculty of Medicine Keio University Hospital