The Fever Clinic Acute Respiratory Cohort (FACTS)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Influenza-like Illness; Acute Respiratory Infections; Community-acquired Pneumonia; Febrile Illnesses; Viral Respiratory Tract Infections
• Intervention / Treatment: Other: No intervention involved

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: YingGang Zhu, Doctor; Phone Number: +8618001637153; Email: robinzyg@gmail.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200040
      • Recruiting
      • Huadong Hospital
      • Contact: XINQI LI; Email: 243138506@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients presenting to fever clinics with acute respiratory infections, aged 18 years or older, who provide informed consent. Both sexes are eligible. Participants are observed under standard clinical care without intervention

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pneumonia Cohort	Other: No intervention involved; This is a observational study so no intervention involved.
Non-Pneumonia Cohort	Other: No intervention involved; This is a observational study so no intervention involved.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Participants Hospitalized for Pneumonia	The percentage of patients who require hospitalization due to radiologically confirmed pneumonia within the 30-day follow-up period.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Symptom Resolution at 24 Hours	Proportion of participants achieving complete resolution of patient-reported symptoms (e.g., fever, myalgia) at 24 hours after enrollment.	24 hours
Rate of Symptom Resolution at 7 Days		7 days
Time to Sustained Symptom Resolution		30 days
All-cause Mortality Rate at 30 Days		30 days
Intensive Care Unit (ICU) Admission Rate at 30 Days		30 days
Change in White Blood Cell (WBC) Count		Baseline, Day 3
Normalization Rate of C-reactive Protein (CRP)		Baseline, Day 7
Change in Procalcitonin (PCT) Level		Baseline, Day 3
Incidence of Acute Exacerbation of Underlying Chronic Diseases		30 days
Rate of Unplanned Medical Visits		30 days

Collaborators and Investigators

• Sponsor: Fudan University
• Collaborators: Huadong Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2025
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: November 24, 2025
• First Submitted That Met QC Criteria: December 11, 2025
• First Posted (Actual): December 12, 2025

Study Record Updates

• Last Update Posted (Actual): December 12, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Fever; Disease Progression; Respiratory Tract Infections; Anti-Bacterial Agents; Community-Acquired Pneumonia
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Respiratory Tract Diseases; Pneumonia; Body Temperature Changes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Community-Acquired Infections; Disease Progression; Respiratory Tract Infections; Fever; Community-Acquired Pneumonia
• Other Study ID Numbers: FACTS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: This is an observational real-world cohort study of patients presenting to fever clinics. Individual participant data (IPD) will not be shared because the dataset contains sensitive personal health information, including demographics, clinical findings, and follow-up details. Data privacy and confidentiality will be strictly maintained in accordance with institutional and ethical guidelines.

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No