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RecruitingNCT07278700FACTSUpdated Dec 12, 2025

The Fever Clinic Acute Respiratory Cohort

An observational study in Acute Respiratory Infections, Febrile Illnesses and Community-acquired Pneumonia, sponsored by Fudan University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-12.

Sponsored by Fudan University · Observational

From the registry’s dates

  • Started Oct 2025; still recruiting 1 year 1 month later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years and older
Sex
All
01

Study 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.

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.

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Conditions studied

  • 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
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In context

Community-Acquired Pneumonia

324 studies on the registry are indexed under Community-Acquired Pneumonia; 77 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 650 across 111 observational studies indexed under Community-Acquired Pneumonia.

Browse Community-Acquired Pneumonia studies →

Lead sponsor

Fudan University is the lead sponsor of 1,315 studies on the registry; 643 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

Exclusion Criteria:

  • Inability to provide independent due to impaired consciousness or other reasons.
  • Inability to comply with the study procedures.
  • Medical to blood sampling, such as severe coagulopathy (e.g., > 3.0, count \< 50 × 10⁹/L).
  • Diagnosed with a terminal illness (e.g., advanced , severe multiple organ failure) and a of less than 3 months.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Target follow-up
30 Days
Patient registry
Yes

Groups and cohorts

  • Pneumonia Cohort

    Other: No intervention involved

  • Non-Pneumonia Cohort

    Other: No intervention involved

Interventions

  • OtherNo intervention involved

    This is a observational study so no intervention involved.

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What researchers measure

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.

    Time frame: 30 days

Secondary outcomes

  1. 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.

    Time frame: 24 hours

  2. Rate of Symptom Resolution at 7 Days

    Time frame: 7 days

  3. Time to Sustained Symptom Resolution

    Time frame: 30 days

  4. All-cause Mortality Rate at 30 Days

    Time frame: 30 days

  5. Intensive Care Unit (ICU) Admission Rate at 30 Days

    Time frame: 30 days

  6. Change in White Blood Cell (WBC) Count

    Time frame: Baseline, Day 3

  7. Normalization Rate of C-reactive Protein (CRP)

    Time frame: Baseline, Day 7

  8. Change in Procalcitonin (PCT) Level

    Time frame: Baseline, Day 3

  9. Incidence of Acute Exacerbation of Underlying Chronic Diseases

    Time frame: 30 days

  10. Rate of Unplanned Medical Visits

    Time frame: 30 days

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 12, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07278700
Lead sponsor
Fudan University
Collaborators
Huadong Hospital
Responsible party
Zhijun Bao (President, Fudan University) — Principal investigator
First posted
Dec 12, 2025
Start date
Oct 10, 2025
Primary completion
Oct 2028 (estimated)
Completion
Oct 2028 (estimated)
Last update
Dec 12, 2025

Study contacts

YingGang Zhu, Doctor
Contact
robinzyg@gmail.com
+8618001637153

Oversight

Data monitoring committee
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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