Skip to content

Clinical trial of a combined detection kit targeting the nucleic acids of four bacteria

Clinical trial of a combined detection kit targeting the nucleic acids of four bacteria

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400082416
Enrollment
Unknown
Registered
2024-03-28
Start date
2021-03-12
Completion date
Unknown
Last updated
2024-04-01

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

Conditions

Bloodstream infection

Interventions

blood culture and Sanger sequencing
Index test:Detection results of the four target bacteria (E. coli, K. pneumoniae, A. baumannii, P. aeruginosa) by digital PCR technology

Sponsors

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Be able to understand the research procedures, voluntarily participate and sign informed consent; 2. Clinicians suspect bloodstream infection; blood culture testing is required and any one of the following is met: 1) Meet the diagnostic criteria for sepsis: SOFA score increment = 2 points or qSOFA = 2 points (early stage); 2) Clinicians highly suspect bloodstream infection, and any one or more of the following clinical characteristics are present: a. Chills; b. Fever (body temperature >38.3?) or hypothermia (body temperature 12*10^9/L or WBC10%; d. PCT>2 times the upper limit of normal.

Exclusion criteria

Exclusion criteria: Anyone who meets any of the following conditions will be excluded: 1) Patients who have been enrolled in this clinical trial before; 2) Special groups such as patients with mental disorders and pregnant women; 3) Involuntarily participate in this study; 4) Samples that the researcher believes should be excluded.

Design outcomes

Primary

MeasureTime frame
Sensitivity;Specificity;Positive coincidence rate;Negative coincidence rate;

Secondary

MeasureTime frame
Total coincidence rate;Kappa index;

Countries

China

Contacts

Public ContactYunsong Yu

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

yvys119@zju.edu.cn+86 138 0579 0432

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026