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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000003964
Enrollment
50
Registered
2010-07-29
Start date
2010-07-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate and severe pneumonia

Interventions

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

Sponsors

Fuji Heavy Industries Ltd Health Insurance Society Ota Hospital: Neurology, Ashikaga Red Cross Hospital :Respiratory internal medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Elderly 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.

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
Evaluation of clinical response after 3 days administration, clinical response at the end of treatment, bacteriological response, serum concentration measurement and PK-PD analysis

Countries

Japan

Contacts

Public ContactMitsuru Sando

Fuji Heavy Industries Ltd Health Insurance Society Ota Hospital Pharmaceutical Department

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026