Clinical trial NCT05965128: Promotion and Application of a New Three-level Etiological Diagnosis Strategy for Fever Clinics in Respiratory Infectious Diseases
Official title: Promotion and Application of a New Three-level Etiological Diagnosis Strategy for Fever Clinics in Respiratory Infectious Diseases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Respiratory Infectious Diseases
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2023-07-28
Enrollment: 1255
Sex: ALL
Minimum age (years): 12
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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;

Primary outcomes:
measure: the detectioin rate of pathogenic microorganism in each step
timeFrame: 48 hours
Secondary outcomes:
measure: hospitalization rate
timeFrame: 48 hours
measure: rate of critical illness
timeFrame: 48 hours
Other outcomes:
Locations:
city: Lanzhou
country: China
facility: Gansu Provincial People's Hospital
state: Gansu
city: Harbin
country: China
facility: Heilongjiang Provincial Hospital
state: Heilongjinag
city: Hohhot
country: China
facility: People's Hospital of Inner Mongolia Autonomous Region
state: Inner Mongolia
city: Suzhou
country: China
facility: The First Affiliated Hospital of Suzhou University
state: Jiangsu
city: Xuzhou
country: China
facility: Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
city: Shenyang
country: China
facility: Shenyang Sixth People's Hospital
state: Liaoning
city: Jinan
country: China
facility: Shandong University Qilu Hospital
state: Shandong
city: Jining
country: China
facility: Jining Public Health Center
state: Shandong
city: Shanghai
country: China
facility: Fudan University Affiliated Huashan Hospital
state: Shanghai
city: Taiyuan
country: China
facility: The First Hospital of Shanxi Medical University
state: Shanxi
city: Kunming
country: China
facility: The First People's Hospital of Yunnan Province
state: Yunnan
city: Rui'an
country: China
facility: Ruian City People's Hospital
state: Zhejiang
Study officials:
References: