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

Respiratory Infectious Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05965128
• Other study ID #: KY2022-955
• Status: Recruiting
• Start date: December 1, 2022
• Est. completion date: December 2027

Study information

• Verified date: July 2023
• Source: Huashan Hospital
• Contact: Wenhong Zhang, M.D.
• Phone: 13801844344
• Email: zhangwenhong[@]fudan.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1255
• Est. completion date: December 2027
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 100 Years

Eligibility

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:

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;

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Respiratory Infectious Diseases

Locations

Country	Name	City	State
China	Heilongjiang Provincial Hospital	Harbin	Heilongjinag
China	People's Hospital of Inner Mongolia Autonomous Region	Hohhot	Inner Mongolia
China	Shandong University Qilu Hospital	Jinan	Shandong
China	Jining Public Health Center	Jining	Shandong
China	The First People's Hospital of Yunnan Province	Kunming	Yunnan
China	Gansu Provincial People's Hospital	Lanzhou	Gansu
China	Ruian City People's Hospital	Rui'an	Zhejiang
China	Fudan University Affiliated Huashan Hospital	Shanghai	Shanghai
China	Shenyang Sixth People's Hospital	Shenyang	Liaoning
China	The First Affiliated Hospital of Suzhou University	Suzhou	Jiangsu
China	The First Hospital of Shanxi Medical University	Taiyuan	Shanxi
China	Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Huashan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the detectioin rate of pathogenic microorganism in each step	the detectioin rate of pathogenic microorganism in each step	48 hours
Secondary	hospitalization rate	hospitalization rate	48 hours
Secondary	rate of critical illness	rate of critical illness	48 hours