The Fever Clinic Acute Respiratory Cohort

NCT07278700 | Recruiting

• 1 other identifier: FACTS
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Respiratory Tract Infections; Fever; Community-Acquired Pneumonia; Anti-Bacterial Agents; Disease Progression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Rate of Symptom Resolution at 24 Hours

  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

Study Arms (2)

Pneumonia Cohort

Other: No intervention involved

Non-Pneumonia Cohort

Other: No intervention involved

Interventions

No intervention involved OTHER

This is a observational study so no intervention involved.

Non-Pneumonia Cohort; Pneumonia Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead
• Huadong Hospital: collaborator

Study Sites (1)

Huadong hospital

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

MeSH Terms

Conditions

Community-Acquired Pneumonia; Respiratory Tract Infections; Fever; Disease Progression

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Central Study Contacts

YingGang Zhu, Doctor

CONTACT

+8618001637153; robinzyg@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 12, 2025
• Study Start: October 10, 2025
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: December 12, 2025

Record last verified: 2025-12

Locations

CN (1)