Acute Respiratory Infections, Community-acquired Pneumonia, Febrile Illnesses, Influenza-like Illness, Viral Respiratory Tract Infections
Conditions
Keywords
Respiratory Tract Infections, Fever, Community-Acquired Pneumonia, Anti-Bacterial Agents, Disease Progression
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.
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
This is a observational study so no intervention involved.
Sponsors
Huadong Hospital
Fudan University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Hospitalized for Pneumonia | 30 days | The percentage of patients who require hospitalization due to radiologically confirmed pneumonia within the 30-day follow-up period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Rate of Symptom Resolution at 24 Hours | 24 hours | Proportion of participants achieving complete resolution of patient-reported symptoms (e.g., fever, myalgia) at 24 hours after enrollment. |
| 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 | — |
| Change in White Blood Cell (WBC) Count | Baseline, Day 3 | — |
Countries
China
Contacts
Primary ContactYingGang Zhu, Doctor
Outcome results
None listed