Promotion and Application of a New Three-level Etiological Diagnosis Strategy for Fever Clinics in Respiratory Infectious Diseases
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Respiratory Infectious Diseases. Basic parameters: 12 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- the detectioin rate of pathogenic microorganism in each step [Time frame: 48 hours]
Secondary outcome measures (2)
- hospitalization rate [Time frame: 48 hours]
- rate of critical illness [Time frame: 48 hours]
Eligibility criteria
Inclusion criteria
- Acute onset within one week;
- 18-70 years old;
- 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
- Unable to collect nasal/nasopharyngeal swab/wash/aspirate due to structural disorder or mental problem.
- Patients with psycological problem or unconsciousness who cannot tell the disease history and cooperate with medical examinations;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-only
Study locations
China · 12 centers
- Gansu Provincial People's Hospital — Lanzhou
- Heilongjiang Provincial Hospital — Harbin
- People's Hospital of Inner Mongolia Autonomous Region — Hohhot
- The First Affiliated Hospital of Suzhou University — Suzhou
- Affiliated Hospital of Xuzhou Medical University — Xuzhou
- Shenyang Sixth People's Hospital — Shenyang
- Shandong University Qilu Hospital — Jinan
- Jining Public Health Center — Jining
- … and 4 more centers
Identifiers
NCT: NCT05965128 · KY2022-955