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Clinical Trial of 15 Combined Detection Kits for Human Respiratory Pathogens (Quantitative Real-time PCR)

Clinical Trial of 15 Combined Detection Kits for Human Respiratory Pathogens (Quantitative Real-time PCR)

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000040432
Enrollment
Unknown
Registered
2020-11-28
Start date
2020-12-08
Completion date
Unknown
Last updated
2021-02-22

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

Conditions

Respiratory disease

Interventions

detection&#32
kit&#32
for&#32
Gold Standard:Culture of viruses or bacteria
Index test:15-item&#32

Sponsors

CHILDREN'S HOSPITAL OF SHANGHAI
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria for the case group: (1) In patients clinically diagnosed with respiratory tract infection, blood routine test was abnormal and CRP was significantly increased. In children (under 18 years old) who needed to be tested for multiple pathogens of Hershish, the case group should include cases of different stages of this disease, so as to reflect all characteristics of this disease; (2) The clinical test sample type was pharyngeal swab; (3) The sample size was not less than 800 L for routine clinical diagnosis and treatment; (4) Complete and traceable sample information includes age, gender, case number, sampling date, clinical diagnosis, etc. See CRF table for details. Inclusion criteria of the control group: (1) Normal physical examination population without respiratory tract infection; (2) The clinical test sample type was pharyngeal swab; (3) The samples are the remaining samples after routine clinical diagnosis and treatment, with a sample surplus of not less than 800 L; (4) Complete and traceable sample information includes age, gender, case number, sampling date, clinical diagnosis, etc. See CRF table for details.

Exclusion criteria

Exclusion criteria: Samples that are not collected and stored as required, samples that cannot be extracted by nucleic acid due to insufficient sample size, sample information that is unclear, samples that are not recorded as required, samples that cannot be traced due to the absence of patient diagnostic information or other factors.

Design outcomes

Primary

MeasureTime frame
Cycle threshold value;

Countries

China

Contacts

Public ContactZhao Linqing, Cao Ling

CHILDREN'S HOSPITAL CAPITAL INSTITUTE OF PEDIATRICS

512063965@qq.com+86 13813830516

Outcome results

None listed

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