Efficacy of high dose doripenem on patients with severe infectious diseases in intensive care units

Efficacy of high dose doripenem on patients with severe infectious diseases in intensive care units - Efficacy of high dose doripenem on patients with severe infectious diseases in intensive care units

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000009396

Enrollment

Registered

2012-12-01

Start date

2011-11-01

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

severe infectious diseases(pneumonia, bacteremia, etc)

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Infectious diseases with at least over two below items, including over 15 of APACHE II score (Vital signs) 1) fever >38C or hypothermia <36C 2) heart rate >90/min 3) respiratory rate >20/min or PaCO2 <32mmHG 4) WBC >12,000/&micro;L or <4,000/&micro;L, or over 10% in stab cells with the shift to left in neutrophil

Exclusion criteria

Exclusion criteria: 1) more less than 16-old years 2) patients who have shown hypersensitivity to any component of beta lactams 3) non-infectious patients with fever 4) patients with causative isolates with no susceptibility to study drug (ex.MRSA, S.maltophila etc.), including metalo-beta-lactamase producing organisms 5) patients in treatment with valproic acid or with seizures and other CNS adverse experiences 6) physician's decision for adequateness in this study

Design outcomes

Primary

Measure	Time frame
clinical outcomes on the day of the final dosing	—

Secondary

Measure	Time frame
1)clinical outcomes on the third and the seventh day 2)duration of dosing 3)bacteriological efficacy after the final dosing 4)adverse effects and clinical examinations	—

Countries

Japan

Contacts

Public ContactKenichiro Fukuda

Showa University school of medicine Department of Emergency Medicine

kennyfukuda511@yahoo.co.jp03-3784-8000

Outcome results