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RecruitingNCT05965128Updated Jul 28, 2023

Promotion and Application of a New Three-level Etiological Diagnosis Strategy for Fever Clinics in Respiratory Infectious Diseases

An observational study in Respiratory Infectious Diseases, sponsored by Huashan Hospital. Recruiting at 12 sites in China. Open to participants aged 12 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-28.

Sponsored by Huashan Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2023, 2 years 10 months ago, but the record still lists the study as recruiting.
  • Started Dec 2022; still recruiting 3 years 10 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
1,255
Ages
12 Years to 100 Years
Sex
All
01

Study summary

Relying on fever clinics, this project evaluates the clinical diagnostic efficiency of the three-level pathogen diagnostic system, monitors changes in respiratory pathogens, and realizes real-time monitoring and early warning of acute respiratory infectious diseases in Shanghai.

Read the detailed description

This study mainly includes subjects who enter the outpatient and emergency departments, fever clinics, and wards of each center from December 2022. According to the clinical manifestations and epidemiological information of the patients, different step-by-step detection methods will be adopted to optimize the allocation of clinical resources and improve the quality of life. This study aims to improve pathogen diagnosis efficiency and achieve regional respiratory early warning.

02

Conditions studied

  • Respiratory Infectious Diseases
03

In context

Communicable Diseases

4,452 studies on the registry are indexed under Communicable Diseases; 521 are open to participants now.

This study's planned enrollment of 1,255 is above the median of 244 across 1,499 observational studies indexed under Communicable Diseases.

Browse Communicable Diseases studies →

Lead sponsor

Huashan Hospital is the lead sponsor of 239 studies on the registry; 102 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

this study enrolled patients who were admitted to the fever clinics and emergency room for influenza-like illness or pneumonia and pathogenic detection was necessary for clincial diagnosis and treatment.

Inclusion criteria

  1. Acute onset within one week;
  2. 18-70 years old;
  3. Present with pneumonia (present with pulmonary signs or radiological changes) or influenza-like illness (including the following symptoms: sudden onset of fever (>38 ℃),plus cough and/or other respiratory symptoms such as shortness of breath plus one or more systemic symptoms (fatigue, headache ect.))

Exclusion criteria

Exclusion Criteria:

  1. Unable to collect nasal/nasopharyngeal swab/wash/aspirate due to structural disorder or mental problem.
  2. Patients with psycological problem or unconsciousness who cannot tell the disease history and cooperate with medical examinations;
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
1,255 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. the detectioin rate of pathogenic microorganism in each step

    the detectioin rate of pathogenic microorganism in each step

    Time frame: 48 hours

Secondary outcomes

  1. hospitalization rate

    hospitalization rate

    Time frame: 48 hours

  2. rate of critical illness

    rate of critical illness

    Time frame: 48 hours

07

Study locations

1 of 12 sites recruiting
  • Gansu Provincial People's Hospital
    Lanzhou, Gansu, China
    Not yet recruiting
  • Heilongjiang Provincial Hospital
    Harbin, Heilongjinag 1500036, China
    Not yet recruiting
  • People's Hospital of Inner Mongolia Autonomous Region
    Hohhot, Inner Mongolia, China
    Not yet recruiting
  • The First Affiliated Hospital of Suzhou University
    Suzhou, Jiangsu, China
    Not yet recruiting
  • Affiliated Hospital of Xuzhou Medical University
    Xuzhou, Jiangsu, China
    Not yet recruiting
  • Shenyang Sixth People's Hospital
    Shenyang, Liaoning, China
    Not yet recruiting
  • Shandong University Qilu Hospital
    Jinan, Shandong, China
    Not yet recruiting
  • Jining Public Health Center
    Jining, Shandong 0537-7970121, China
    Not yet recruiting
  • Fudan University Affiliated Huashan Hospital
    Shanghai, Shanghai 200040, China
    • Hongyu Wang · Contact · 17717366509
    Recruiting
  • The First Hospital of Shanxi Medical University
    Taiyuan, Shanxi, China
    Not yet recruiting
  • The First People's Hospital of Yunnan Province
    Kunming, Yunnan, China
    Not yet recruiting
  • Ruian City People's Hospital
    Rui'an, Zhejiang, China
    Not yet recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05965128
Lead sponsor
Huashan Hospital
Responsible party
Wen-hong Zhang (Director of Division of Infectious Diseases, Huashan Hospital) — Principal investigator
First posted
Jul 28, 2023
Start date
Dec 1, 2022
Primary completion
Dec 2023 (estimated)
Completion
Dec 2027 (estimated)
Last update
Jul 28, 2023

Study contacts

Wenhong Zhang, M.D.
Contact
zhangwenhong@fudan.edu.cn
13801844344
Jingwen Ai, M.D.
Contact
Jingwenai1990@126.com
13764990804

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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