Massive study aims to unlock Pneumonia's secrets
NCT ID NCT07567911
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study will follow about 2,700 adults with pneumonia to track their recovery and understand why some become severely ill. Researchers will collect health data and samples to find patterns that predict worsening. The goal is to improve how doctors assess risk and make treatment decisions, not to test a new drug or cure.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 2,700 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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May 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 <!-- --> 1. Age ≥ 18 years old; 2. Having infection-related symptoms or signs (such as fever, cough, sputum production, elevated white blood cells, etc.), clinically suspected of pneumonia; 3. All pathogen tests are negative within 3 days after admission; 4. Time from onset to admission ≤ 72 hours; 5. Signed written informed consent. 2.2 Exclusion Criteria <!-- --> 1. End-stage diseases (such as expected survival \< 48 hours); 2. Long-term immunosuppressive therapy; 3. Pregnant or lactating women;
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fifth Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
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Other studies related to the condition(s) this trial covers.
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