Skip to content

Clinical Value of High-throughput PCR in Early Diagnosis and Guiding Anti-infective therapy of Suspected Bloodstream Infections with Sepsis.

Clinical Value of High-throughput PCR in Early Diagnosis and Guiding Anti-infective therapy of Suspected Bloodstream Infections with Sepsis.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300073545
Enrollment
Unknown
Registered
2023-07-13
Start date
2023-07-20
Completion date
Unknown
Last updated
2023-07-16

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

Conditions

Sepsis

Interventions

Index test:High-throughput PCR

Sponsors

Zhongshan Hospital,Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: (1)Male or female >= 18 years old; (2)Patients who meet the criteria of Sepsis 3.0 proposed by the 2016 International expert consensus on sepsis, that is, for patients with infection or suspected infection, when sepsis related sequential organ Failure Assessment (Sequential Organ Failure Assessment,SOFA), An increase of SOFA score =2 points from baseline can diagnose sepsis, and three clinical experts agreed that bloodstream infection was highly suspected. (3)Length of stay>24 hours; (4)Sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1)Mental disorders; (2)Pregnant and lactating women; (3)Participated in other clinical studies

Design outcomes

Primary

MeasureTime frame
sensitivity;specificity;The total coincidence rate between the test results and blood culture;

Secondary

MeasureTime frame
Positive predictive value;Negative predictive value;misdiagnosis rate;miss rate;

Countries

China

Contacts

Public ContactZhenju Song

Zhongshan Hospital,Fudan University

song.zhenju@zs-hospital.sh.cn+86 138 1660 7453

Outcome results

None listed

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