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

NCT ID: NCT05965128

Last Updated: 2023-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1255 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-01

Study Completion Date

2027-12-31

Brief Summary

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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

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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.

Conditions

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Respiratory Infectious Diseases

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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;
Minimum Eligible Age

12 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Huashan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Wen-hong Zhang

Director of Division of Infectious Diseases

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Gansu Provincial People's Hospital

Lanzhou, Gansu, China

Site Status NOT_YET_RECRUITING

Heilongjiang Provincial Hospital

Harbin, Heilongjinag, China

Site Status NOT_YET_RECRUITING

People's Hospital of Inner Mongolia Autonomous Region

Hohhot, Inner Mongolia, China

Site Status NOT_YET_RECRUITING

The First Affiliated Hospital of Suzhou University

Suzhou, Jiangsu, China

Site Status NOT_YET_RECRUITING

Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Site Status NOT_YET_RECRUITING

Shenyang Sixth People's Hospital

Shenyang, Liaoning, China

Site Status NOT_YET_RECRUITING

Shandong University Qilu Hospital

Jinan, Shandong, China

Site Status NOT_YET_RECRUITING

Jining Public Health Center

Jining, Shandong, China

Site Status NOT_YET_RECRUITING

Fudan University Affiliated Huashan Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

The First Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Site Status NOT_YET_RECRUITING

The First People's Hospital of Yunnan Province

Kunming, Yunnan, China

Site Status NOT_YET_RECRUITING

Ruian City People's Hospital

Rui’an, Zhejiang, China

Site Status NOT_YET_RECRUITING

Countries

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China

Central Contacts

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Wenhong Zhang, M.D.

Role: CONTACT

Phone: 13801844344

Email: [email protected]

Jingwen Ai, M.D.

Role: CONTACT

Phone: 13764990804

Email: [email protected]

Facility Contacts

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Xiaojun Chen, M.D.

Role: primary

Xiaoli Hu, M.D.

Role: primary

Jihong An, M.D.

Role: primary

Xiaoping Huang, M.D.

Role: primary

Xuebing Yan, M.D.

Role: primary

Ye Gu, M.D.

Role: primary

Lintao Sai, M.D.

Role: primary

Kaixue Lv, M.D.

Role: primary

Hongyu Wang

Role: primary

Liaoyun Zhang, M.D.

Role: primary

Jiawei Geng, M.D.

Role: primary

Liang Hong, M.D.

Role: primary

Other Identifiers

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KY2022-955

Identifier Type: -

Identifier Source: org_study_id