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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05965128

Enrollment

1255

Registered

2023-07-28

Start date

2022-12-01

Completion date

2027-12-31

Last updated

2023-07-28

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

Conditions

Respiratory Infectious Diseases

Brief 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.

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

12 Years to 100 Years

Healthy volunteers

Yes

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;

Design outcomes

Primary

Measure	Time frame	Description
the detectioin rate of pathogenic microorganism in each step	48 hours	the detectioin rate of pathogenic microorganism in each step

Secondary

Measure	Time frame	Description
hospitalization rate	48 hours	hospitalization rate
rate of critical illness	48 hours	rate of critical illness

Countries

China

Contacts

Primary ContactWenhong Zhang, M.D.

zhangwenhong@fudan.edu.cn13801844344

Backup ContactJingwen Ai, M.D.

Jingwenai1990@126.com13764990804

Outcome results