Clinical evaluation study of 'DiagnoSep', the bacterial detection kit

Clinical evaluation study of 'DiagnoSep', the bacterial detection kit - Evaluation study of the bacterial detection kit

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000015333

Enrollment

Registered

2014-10-03

Start date

2014-10-05

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

Sepsis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with suspected sepsis. As follows, patient exhibits two or more of the following criteria; Body temperature: >38C or <36C Heart rate: 90 beats/min Respiration rate: >20 breaths/min or PaCO2 < 32 mm Hg White blood cell count: >12,000/uL, <4000/uL, or > 10% immature forms , and suspected or proven infection.

Exclusion criteria

Exclusion criteria: White blood cell count: <3,000/uL Non-conforming cases judged by doctors; like in case of severe anemia, less-volume of blood sampling availability for this study due to severe medical conditions, and so on.

Design outcomes

Primary

Measure	Time frame
The relationship between sepsis and the results of DiagnoSep.	—

Secondary

Measure	Time frame
The relationship between sepsis, bacterial infection, and the results obtained from DiagnoSep and HybriSep.	—

Countries

Japan

Contacts

Public ContactHiroshi Kakeya

Osaka City University Infection Control Science

kakeya@med.osaka-cu.ac.jp06-6645-3784

Outcome results