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Microbiological Diagnostic Performance of Probe Capture Based Targeted Next-generation Sequencing When Applied to Suspected Bloodstream Infection

Microbiological Diagnostic Performance of Probe Capture Based Targeted Next-generation Sequencing When Applied to Suspected Bloodstream Infection

Status
Recruiting
Phases
Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300077934
Enrollment
Unknown
Registered
2023-11-24
Start date
2023-11-24
Completion date
Unknown
Last updated
2023-11-27

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

Conditions

Infectious diseases

Interventions

Gold Standard:clinically diagnosed as bloodstream infection or noninfectious fever
Index test:blood culture, blood mNGS, blood tNGS

Sponsors

Zhongshan Hospital, Fudan University, Shanghai, China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
14 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1) Age = 14 years old, regardless of gender; 2) Meets the diagnostic criteria for systemic inflammatory response syndrome (SIRS); 3) Shivering and fever, with a body temperature greater than 38.5 ?; 4) At least one of the biomarkers increased: blood routine white blood cell count, C-reactive protein, erythrocyte sedimentation rate, and procalcitonin; 5) The infection is severe and suspected to be bloodstream infection which cannot be explained by local infection.

Exclusion criteria

Exclusion criteria: 1) When admitted, fever was clearly caused by non-infectious factors (such as tumors, rheumatic immune system diseases, etc.); 2) Unclear clinical diagnosis at discharge/death; 3) Patients who refuse to undergo blood culture, blood mNGS, blood tNGS; 4) Patients who are not suitable to participate in the study determined by the researcher.

Design outcomes

Primary

MeasureTime frame
sensitivity;specificity;Positive predictive value;Negative predictive value;

Countries

China

Contacts

Public ContactHu Bijie

Zhongshan Hospital, Fudan University, Shanghai, China

hu.bijie@zs-hospital.sh.cn+86 136 0162 1604

Outcome results

None listed

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