The Fever Clinic Acute Respiratory Cohort
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No intervention involved.
- Who it may be relevant to
- Registry conditions: Acute Respiratory Infections, Febrile Illnesses, Community-acquired Pneumonia, Viral Respiratory Tract Infections. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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.
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.
Interventions
- Other No intervention involved
This is a observational study so no intervention involved.
Primary outcome measures
- Proportion of Participants Hospitalized for Pneumonia [Time frame: 30 days]
Secondary outcome measures (10)
- Rate of Symptom Resolution at 24 Hours [Time frame: 24 hours]
- Rate of Symptom Resolution at 7 Days [Time frame: 7 days]
- Time to Sustained Symptom Resolution [Time frame: 30 days]
- All-cause Mortality Rate at 30 Days [Time frame: 30 days]
- Intensive Care Unit (ICU) Admission Rate at 30 Days [Time frame: 30 days]
- Change in White Blood Cell (WBC) Count [Time frame: Baseline, Day 3]
- Normalization Rate of C-reactive Protein (CRP) [Time frame: Baseline, Day 7]
- Change in Procalcitonin (PCT) Level [Time frame: Baseline, Day 3]
- Incidence of Acute Exacerbation of Underlying Chronic Diseases [Time frame: 30 days]
- Rate of Unplanned Medical Visits [Time frame: 30 days]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Huadong hospital — Shanghai
Identifiers
NCT: NCT07278700 · FACTS