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Research and development of pathogen diagnosis and analysis technology based on single molecule sequencing in severe pediatric infection

Research and development of pathogen diagnosis and analysis technology based on single molecule sequencing in severe pediatric infection

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200059605
Enrollment
Unknown
Registered
2022-05-04
Start date
2024-05-01
Completion date
Unknown
Last updated
2024-05-27

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

Conditions

severe pediatric infection

Interventions

Gold Standard:Gold standard for pathogen diagnosis: culture or qPCR of sterile specimens.
Index test:pathogen diagnosis and analysis technology based on single molecule sequencing in severe pediatric infection

Sponsors

The Children's Hospital of Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: The following items shall be met: 1. < 18 years old 2. Severe infection, any of the following five items: (1) sepsis, severe sepsis and septic shock (2) severe pneumonia (3) central nervous system infection (4) severe abdominal infection (5) severe cases in major public health emergencies

Exclusion criteria

Exclusion criteria: Compliance with any of the following items is excluded: 1. Unqualified samples: for example, the samples are contaminated, the quantity of samples is insufficient, or the samples are placed for a long time 2. Children who the researchers believe are not suitable to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Pathogen detection rate;qPCR;Sensitivity;Specificity;Positive predictive value ;Negative predictive value ;

Countries

China

Contacts

Public ContactQiang Shu

The Children's Hospital, Zhejiang University School of Medicine

shuqiang@zju.edu.cn+86 139 0650 0193

Outcome results

None listed

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