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NCT Number: NCT05965128

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

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.

Recruiting

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Key information

Age range

12 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Gansu Provincial People's Hospital, Lanzhou, Gansu, China

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Primary outcomes

  1. the detectioin rate of pathogenic microorganism in each step

    Time frame: 48 hours

    the detectioin rate of pathogenic microorganism in each step

Secondary outcomes

  1. hospitalization rate

    Time frame: 48 hours

    hospitalization rate

  2. rate of critical illness

    Time frame: 48 hours

    rate of critical illness

Study contacts

Contact information is provided by the study sponsor or research team.

Jingwen Ai, M.D.

CONTACT

[email protected]

13764990804

Wenhong Zhang, M.D.

CONTACT

[email protected]

13801844344

Sponsors and collaborators

Lead sponsor

Huashan Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2027
First posted
Jul 28, 2023
Registry last updated
Jul 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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