Acute Respiratory InfectionsFACTSNCT07278700
The Fever Clinic Acute Respiratory Cohort
An observational study of Acute Respiratory Infections and Febrile Illnesses, run by Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Infections, Febrile Illnesses, Community-acquired Pneumonia
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2025to Oct 2028
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Huadong hospital
Shanghai, Shanghai Municipality, 200040
XINQI LI, 243138506@qq.com
About this study
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
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.
Read the 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.
- Conditions
- Acute Respiratory Infections, Febrile Illnesses, Community-acquired Pneumonia, Viral Respiratory Tract Infections, Influenza-like Illness
- Being tested
- No intervention involved
- Keywords
- Respiratory Tract Infections, Fever, Community-Acquired Pneumonia, Anti-Bacterial Agents, Disease Progression
- Medical subject headings
- Community-Acquired Pneumonia, Respiratory Tract Infections, Fever, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention involvedOther
This is a observational study so no intervention involved.
| Study group | Role | What they receive |
|---|---|---|
| Pneumonia Cohort | Not described Receives: Other: No intervention involved | |
| Non-Pneumonia Cohort | Not described Receives: Other: No intervention involved |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (10)
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.
Measured: 24 hours
Rate of Symptom Resolution at 7 Days
Measured: 7 days
Time to Sustained Symptom Resolution
Measured: 30 days
All-cause Mortality Rate at 30 Days
Measured: 30 days
Intensive Care Unit (ICU) Admission Rate at 30 Days
Measured: 30 days
Change in White Blood Cell (WBC) Count
Measured: Baseline, Day 3
Normalization Rate of C-reactive Protein (CRP)
Measured: Baseline, Day 7
Change in Procalcitonin (PCT) Level
Measured: Baseline, Day 3
Incidence of Acute Exacerbation of Underlying Chronic Diseases
Measured: 30 days
Rate of Unplanned Medical Visits
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start10 Oct 2025
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory InfectionsStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Huadong Hospital
- Responsible party
- Principal investigator, Zhijun Bao, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07278700
- Sponsor's protocol ID
- FACTS
- Acronym
- FACTS
- Status last verified
- Dec 2025
- First submitted
- 24 Nov 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07278700
- Acronym / sponsor ID
- FACTS / FACTS
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Huadong Hospital
- Study start
- 10 Oct 2025 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 12 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pneumonia Cohort | – | Other: No intervention involved |
| Non-Pneumonia Cohort | – | Other: No intervention involved |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention involvedThis is a observational study so no intervention involved. | Other | Non-Pneumonia Cohort, Pneumonia Cohort |
Primary outcome
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.
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Individual participant dataSharing planned: Undecided. 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.
Related trials for Acute Respiratory Infections
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
Not yet recruiting
Influence of Patient Positioning During Nasal Lavage
Acute Upper Respiratory Tract Infections, Nasal Obstruction
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Infections and Febrile Illnesses, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact YingGang Zhu, Doctor (+8618001637153, robinzyg@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants Hospitalized for Pneumonia (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.