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Rapid diagnosis of pathogens in patients with bloodstream infection by NeoHiT-PCR

Rapid diagnosis of pathogens in patients with bloodstream infection by NeoHiT-PCR

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400088499
Enrollment
Unknown
Registered
2024-08-20
Start date
2024-08-20
Completion date
Unknown
Last updated
2024-08-26

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

Conditions

Bloodstream infection

Interventions

Index test:NeoHiT-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
The total coincidence rate between the test results and blood culture;

Secondary

MeasureTime frame
specificity;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