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Severe PneumoniaNCT07567911

A Prospective Observational Cohort Study Protocol for Disease Severity Stratification and Prognosis Assessment in Patients With Pneumonia

An observational study of Severe Pneumonia and Pneumonia, run by Zhonghao Fang at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This is a prospective, multicenter observational cohort study involving approximately 2,700 patients, designed to delineate the natural history of pneumonia by tracking the complete clinical course and dynamic multi-omics evolution from the acute phase to recovery; the study aims to quantify severe conversion rates… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Severe Pneumonia, Pneumonia
How many people
2,700 participants
Where
1 siteChina
Study dates
1 May 2026to 28 May 2028
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: Based on the reported overall hospital mortality rate of pneumonia of 0.80%1, to ensure the accuracy of the estimation of the primary outcome (overall hospital mortality rate), a two-sided significance level of α = 0.05 was set, with an allowable absolute error of δ = 0.6%. Using the single sample rate formula, the minimum sample size N ≈ 2010 cases was calculated. Considering that this study is a real-world observational cohort design and needs to meet requirements such as multi-subgroup analysis, sensitivity testing, and machine learning modeling, the final plan is to include at least 2400 patients with pneumonia. Given that severe pneumonia accounts for approximately 13.58% to 20.05% of pneumonia patients1,2, an epidemiological proportion of 15% (i.e., 1.5:8.5) was taken. It is estimated that there will be approximately 360 patients with severe pneumonia and about 2040 patients with non-severe pneumonia. Additionally, this study also included 300 hospitalized patients with suspected

  1. Inclusion and Exclusion Criteria for Pneumonia Patients 1.1 Inclusion Criteria 1) Age ≥ 18 years old; 2) Meeting the diagnostic criteria for pneumonia (acute onset + new infiltrates on imaging); 3) Time from onset to admission ≤ 72 hours; 4) Signed written informed consent. 1.1.1 Inclusion Criteria for Severe Pneumonia Patients A diagnosis of "severe pneumonia" can be made if one of the main criteria or ≥ 3 of the secondary criteria are met. Main Criteria: ① Requires mechanical ventilation with tracheal intubation ② Requires vasopressor drugs after aggressive fluid resuscitation for septic shock Secondary Criteria:
  • Respiratory rate ≥ 30 breaths/min
  • PaO₂/FiO₂ ≤ 250 mm Hg
  • Multiple lobe infiltrates
  • Confusion and/or disorientation ⑤ Blood urea nitrogen ≥ 20 mg/dL ⑥ Leukopenia (WBC < 4×10⁹/L) ⑦ Thrombocytopenia (PLT < 100×10⁹/L) ⑧ Decreased body temperature (central body temperature < 36 ℃) ⑨ Hypotension requiring fluid resuscitation 1.2 Exclusion Criteria
  1. End-stage diseases (such as expected survival < 48 hours);
  2. Long-term immunosuppressive therapy (prednisone > 20mg/d for more than 3 weeks, or neutropenia after chemotherapy);
  3. Pregnant or lactating women. 2. Inclusion and Exclusion Criteria for Patients with Suspected Infection but Negative Pathogen Testing 2.1 Inclusion Criteria <!-- -->
  4. Age ≥ 18 years old;
  5. Having infection-related symptoms or signs (such as fever, cough, sputum production, elevated white blood cells, etc.), clinically suspected of pneumonia;
  6. All pathogen tests are negative within 3 days after admission;
  7. Time from onset to admission ≤ 72 hours;
  8. Signed written informed consent. 2.2 Exclusion Criteria <!-- -->
  9. End-stage diseases (such as expected survival < 48 hours);
  10. Long-term immunosuppressive therapy;
  11. Pregnant or lactating women;

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Liang Peng, Doctor contact

86-020-85959142

pl_206@126.com

China1 site

  • Fifth Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong

    Liang Peng, Doctor, 86-020-85959142, pl_206@126.com

Other trials in China

About this study

This is a prospective, multicenter observational cohort study involving approximately 2,700 patients, designed to delineate the natural history of pneumonia by tracking the complete clinical course and dynamic multi-omics evolution from the acute phase to recovery; the study aims to quantify severe conversion rates and mortality by comparing baseline characteristics, pathogen distribution, and immune response trajectories between severe and non-severe groups, ultimately revealing the underlying molecular mechanisms of disease progression and optimizing clinical risk stratification strategies.

Keywords
pneumonia, severe pneumonia
Medical subject headings
Pneumonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07567911
Study groupRoleWhat they receive
pneumoniaNot described
Severe pneumoniaNot described
Non-infection control groupNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 28-day all-cause mortality

    Measured: 28-day period following enrollment

Secondary outcomes (6)

  1. The incidence rate of patients in the non-severe group progressing to severe condition

    Measured: 28-day period following enrollment

  2. Time taken for the non-severe group to progress to the severe stage

    Measured: 28-day period following enrollment

  3. Duration of ICU stay

    Measured: 28-day period following enrollment

  4. Duration of mechanical ventilation

    Measured: 28-day period following enrollment

  5. Total hospitalization days

    Measured: 28-day period following enrollment

  6. 28-day readmission rate

    Measured: 28-day period following enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2026
  2. Study start1 May 2026 (estimated)
  3. Primary completion1 May 2026 (estimated)
  4. Study completion28 May 2028 (estimated)

Resources

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
2,700 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07567911
Sponsor's protocol ID
P-2026-001
Status last verified
Apr 2026
First submitted
28 Apr 2026
Last updated
5 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Due to concerns over patient privacy and confidentiality issues, the individual patient data (IPD) may not be shared.

Questions about this trial

What is this clinical trial studying?

An observational study of Severe Pneumonia and Pneumonia, run by Zhonghao Fang 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?

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: opening soon, as of the sponsor's last update on 5 May 2026. 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 Liang Peng, Doctor (86-020-85959142, pl_206@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

28-day all-cause mortality (time frame: 28-day period following enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07567911.

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 5 May 2026.

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