NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000003964

Registered date:29/07/2010

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

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedModerate and severe pneumonia
Date of first enrollment2010/07/01
Target sample size50
Countries of recruitmentJapan
Study typeInterventional
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 OutcomeEvaluation of clinical response after 3 days administration, clinical response at the end of treatment, bacteriological response, serum concentration measurement and PK-PD analysis
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum65years-old
Age maximumNot applicable
GenderMale and Female
Include criteriaElderly patients aged 65 and over regardless of underlying disease. Severity levels of pneumonia are classified by the severity criteria according to "Guidelines for the management of respiratory infections, 2008" edited by The Japanese Respiratory Society.
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

Contact

public contact
Name Mitsuru Sando
Address Hachiman-cho29-5,Ota-shi,Gunma-ken Japan
Telephone
E-mail
Affiliation Fuji Heavy Industries Ltd Health Insurance Society Ota Hospital Pharmaceutical Department
scientific contact
Name Yoshitake Sato
Address Hachiman-cho29-5,Ota-shi,Gunma-ken Japan
Telephone
E-mail
Affiliation Fuji Heavy Industries Ltd Health Insurance Society Ota Hospital Pediatrics