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The Fever Clinic Acute Respiratory Cohort (FACTS)

Fudan University logo

Fudan University

Status

Enrolling

Conditions

Acute Respiratory Infections
Influenza-like Illness
Community-acquired Pneumonia
Viral Respiratory Tract Infections
Febrile Illnesses

Treatments

Other: No intervention involved

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

This prospective cohort study aims to characterize the natural progression and outcomes of acute respiratory infections among patients presenting to fever clinics. At enrollment, patients' clinical symptoms, laboratory findings, and chest imaging data will be collected. Longitudinal follow-up will be conducted to evaluate disease progression, complications, and long-term outcomes.

As an observational study, no interventions are involved; all patients receive routine clinical management as directed by their attending physicians. This real-world study design enables the assessment of the natural course of acute respiratory infections and the identification of factors associated with clinical outcomes.

Full description

This prospective cohort study aims to characterize the natural history and outcomes of acute respiratory infection in patients presenting to fever clinics. Upon enrollment, patients' clinical symptoms, laboratory parameters, and chest imaging data will be collected. Subsequent longitudinal follow-up will be performed to assess disease progression, complications, and long-term outcomes.

As an observational study, no interventions are implemented; all patients receive standard-of-care management as determined by their attending physicians. This real-world study design allows for the evaluation of the natural progression of acute respiratory infections and the identification of factors associated with clinical outcomes.

Enrollment

1,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age ≥ 18 years (based on official identification document).
  • Presence of fever at the time of visit or within 24 hours prior to the visit, defined as a documented temperature of ≥37.3°C axillary/tympanic, ≥37.8°C orally, or ≥38.0°C rectally.
  • The primary cause of fever, as determined by the attending physician, is a respiratory tract infection.
  • Blood draw is required as part of standard clinical care.
  • Ability to comprehend the study's purpose, procedures, and potential risks, and willingness to provide written informed consent.

Exclusion criteria

  • Inability to provide independent informed consent due to impaired consciousness or other reasons.
  • Inability to comply with the study procedures.
  • Medical contraindications to blood sampling, such as severe coagulopathy (e.g., INR > 3.0, platelet count < 50 × 10⁹/L).
  • Diagnosed with a terminal illness (e.g., advanced malignancy, severe multiple organ failure) and a life expectancy of less than 3 months.

Trial design

1,000 participants in 2 patient groups

Pneumonia Cohort
Treatment:
Other: No intervention involved
Non-Pneumonia Cohort
Treatment:
Other: No intervention involved

Trial contacts and locations

1

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Central trial contact

YingGang Zhu, Doctor

Data sourced from clinicaltrials.gov

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