New diagnostic strategy for respiratory infections in fever clinics

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

This study is testing a new way to quickly diagnose respiratory infections in patients with fever and cough to help doctors provide better care.

Quick facts

• Study type: Observational
• Enrollment: 1255 (estimated)
• Ages: 12 Years to 100 Years
• Sex: All
• Sponsor: Huashan Hospital (other)
• Locations: 12 sites (Lanzhou, Gansu and 11 other locations)
• Trial ID: NCT05965128 on ClinicalTrials.gov

What this trial studies

This project evaluates the effectiveness of a three-level pathogen diagnostic system in fever clinics to enhance the diagnosis of respiratory infectious diseases. It involves monitoring changes in respiratory pathogens and aims to provide real-time alerts for acute respiratory infections in Shanghai. Patients presenting with pneumonia or influenza-like symptoms will be assessed using step-by-step detection methods to optimize clinical resource allocation and improve patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 who have acute respiratory symptoms and present with pneumonia or influenza-like illness.

Not a fit: Patients with structural disorders preventing sample collection or those unable to cooperate due to psychological issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly enhance the speed and accuracy of diagnosing respiratory infections, leading to better patient management.

How similar studies have performed: While similar diagnostic strategies have been explored, this specific three-level approach is novel and has not been widely tested.

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;

Where this trial is running

Lanzhou, Gansu and 11 other locations

• Gansu Provincial People's Hospital — Lanzhou, Gansu, China (NOT_YET_RECRUITING)
• Heilongjiang Provincial Hospital — Harbin, Heilongjinag, China (NOT_YET_RECRUITING)
• People's Hospital of Inner Mongolia Autonomous Region — Hohhot, Inner Mongolia, China (NOT_YET_RECRUITING)
• The First Affiliated Hospital of Suzhou University — Suzhou, Jiangsu, China (NOT_YET_RECRUITING)
• Affiliated Hospital of Xuzhou Medical University — Xuzhou, Jiangsu, China (NOT_YET_RECRUITING)
• Shenyang Sixth People's Hospital — Shenyang, Liaoning, China (NOT_YET_RECRUITING)
• Shandong University Qilu Hospital — Jinan, Shandong, China (NOT_YET_RECRUITING)
• Jining Public Health Center — Jining, Shandong, China (NOT_YET_RECRUITING)
• Fudan University Affiliated Huashan Hospital — Shanghai, Shanghai Municipality, China (RECRUITING)
• The First Hospital of Shanxi Medical University — Taiyuan, Shanxi, China (NOT_YET_RECRUITING)
• The First People's Hospital of Yunnan Province — Kunming, Yunnan, China (NOT_YET_RECRUITING)
• Ruian City People's Hospital — Rui’an, Zhejiang, China (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Wenhong Zhang, M.D.

Conditions: Respiratory Infectious Diseases