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Multicenter evaluation of the Verigene Gram-Negative Blood Culture Nucleic Acid Test on the impact of resistance gene determinant for the prediction of susceptibility of Enterobacteriaceae to third-generation cephalosporin in Japan

Multicenter evaluation of the Verigene Gram-Negative Blood Culture Nucleic Acid Test on the impact of resistance gene determinant for the prediction of susceptibility of Enterobacteriaceae to third-generation cephalosporin in Japan - Gram negative bacteremia (Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca or Proteus spp.)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000018119
Enrollment
100
Registered
2015-06-30
Start date
2015-07-01
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

Gram negative bacteremia (Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca or Proteus spp.)

Interventions

None listed

Sponsors

Tsukuba Medical Center Hospital
Lead Sponsor
Tsukuba Medical Center Hospital Seirei Hamamatsu General Hospital Seirei Mikatahara General Hospital Hitachi General Hospital Chutoen General Medical Center Akashi Medical Center Miroku Medical Laboratory Inc.
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (i)Tsukuba Medical Center Hospital The blood of Gram negative bacteremia detected by the BacT/ALERT 3D system (ii)Other hospitals or the Miroku Medical Laboratory Strains of Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca or Proteus spp. without in vitro susceptibility to third-generation cephalosporin (cefotaxime MIC = 2ug/mL or more) isolated from the blood of positive blood culture bottles incubated by automated blood culture systems.

Exclusion criteria

Exclusion criteria: (i) If strains and patient information are not available for clinical research purpose (ii) If evaluation with Verigene system is not able to be performed

Design outcomes

Primary

MeasureTime frame
Cefotaxime susceptibility of Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Proteus spp. when resistance genes are not detected by Verigene system with BC-GN panel

Secondary

MeasureTime frame
(i)Susceptibility of each Enterobacteriaceae to cefotaxime when resistance genes are not detected by Verigene system with BC-GN panel (ii)Detection rate of resistance genes by Verigene BC-GN panel among each Enterobacteriaceae with non-susceptible to cefotaxime (iii)Antimicrobial susceptibilities of each Enterobacteriaceae when blaCTX-M is detected by Verigene system with BC-GN panel

Countries

Japan

Contacts

Public ContactHiromichi Suzuki

Tsukuba Medical Center Hospital Division of Infectious Diseases, Department of Medicine/Department of Clinical Laboratory Medicine

hsuzuki@tmch.or.jp81-29-851-3511

Outcome results

None listed

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