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Clinical application of pathogen nucleic acid detection kit based on digital PCR technology in bloodstream infection of critically ill patients

Clinical application of pathogen nucleic acid detection kit based on digital PCR technology in bloodstream infection of critically ill patients

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100047526
Enrollment
Unknown
Registered
2021-06-20
Start date
2021-06-08
Completion date
Unknown
Last updated
2022-02-21

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

Conditions

Bloodstream Infection

Interventions

Gold Standard:Blood culture.

Sponsors

Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Aged over 18 years, and the informed consent form has been signed; 2.In line with the indications for blood culture retention, and conditions for simultaneous blood culture testing; (1)Heat >=38 ? or low temperature <=-36 ?; (2)Chills, leukocytosis (count greater than 10.0x10^9/L, especially when "nucleus shifts to the left"); (3)Skin and mucous membrane bleeding, coma, multiple organ failure, hypotension; (4)C-reactive protein increased and respiration accelerated, patients with hematologic diseases appeared granulocytopenia, thrombocytopenia, etc.; (5)The clinician judges and considers critically ill patients who may have bloodstream infections.

Exclusion criteria

Exclusion criteria: 1.Mental disorders, pregnant women and other special populations; 2.Sample exclusion criteria: (1)Insufficient sample volume; (2)Severely hemolyzed samples; (3)Use samples of anticoagulants other than those required by the product; (4)Samples that have not been preserved according to the preservation conditions; (5)Samples with cross-contamination or unidentified impurities; (6)Samples whose sample information is confusing and cannot be traced.

Design outcomes

Primary

MeasureTime frame
Sensitivity;Specificity;Total coincidence rate;

Countries

China

Contacts

Public ContactQu Hongping

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

hongpingqu0412@hotmail.com+86 13641801889

Outcome results

None listed

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