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NCT Number: NCT07278700

The Fever Clinic Acute Respiratory Cohort

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

No intervention involved

Other

This is a observational study so no intervention involved.

Primary outcomes

  1. Proportion of Participants Hospitalized for Pneumonia

    Time frame: 30 days

    The percentage of patients who require hospitalization due to radiologically confirmed pneumonia within the 30-day follow-up period.

Secondary outcomes

  1. Rate of Symptom Resolution at 24 Hours

    Time frame: 24 hours

    Proportion of participants achieving complete resolution of patient-reported symptoms (e.g., fever, myalgia) at 24 hours after enrollment.

  2. Rate of Symptom Resolution at 7 Days

    Time frame: 7 days

  3. Time to Sustained Symptom Resolution

    Time frame: 30 days

  4. All-cause Mortality Rate at 30 Days

    Time frame: 30 days

  5. Intensive Care Unit (ICU) Admission Rate at 30 Days

    Time frame: 30 days

  6. Change in White Blood Cell (WBC) Count

    Time frame: Baseline, Day 3

  7. Normalization Rate of C-reactive Protein (CRP)

    Time frame: Baseline, Day 7

  8. Change in Procalcitonin (PCT) Level

    Time frame: Baseline, Day 3

  9. Incidence of Acute Exacerbation of Underlying Chronic Diseases

    Time frame: 30 days

  10. Rate of Unplanned Medical Visits

    Time frame: 30 days

Study contacts

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

YingGang Zhu, Doctor

CONTACT

[email protected]

+8618001637153

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Collaborators

  • Huadong Hospital

Registry information

Official study title

The Fever Clinic Acute Respiratory Cohort (FACTS): A Prospective Real-World Cohort Study of Patients Presenting to Fever Clinics: Clinical Features, Laboratory and Radiographic Findings, and Long-Term Outcomes of Acute Respiratory Infections

Acronym: FACTS

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Dec 12, 2025
Registry last updated
Dec 12, 2025

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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