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NCT Number: NCT07567911

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fifth Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Location contact

Liang Peng, Doctor

CONTACT

[email protected]

86-020-85959142

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

  • End-stage diseases (such as expected survival < 48 hours);
  • Long-term immunosuppressive therapy (prednisone > 20mg/d for more than 3 weeks, or neutropenia after chemotherapy);
  • Pregnant or lactating women. 2. Inclusion and Exclusion Criteria for Patients with Suspected Infection but Negative Pathogen Testing 2.1 Inclusion Criteria

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  • Age ≥ 18 years old;
  • Having infection-related symptoms or signs (such as fever, cough, sputum production, elevated white blood cells, etc.), clinically suspected of pneumonia;
  • All pathogen tests are negative within 3 days after admission;
  • Time from onset to admission ≤ 72 hours;
  • Signed written informed consent. 2.2 Exclusion Criteria

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  • End-stage diseases (such as expected survival < 48 hours);
  • Long-term immunosuppressive therapy;
  • Pregnant or lactating women;

Treatment and study plan

Primary outcomes

  1. 28-day all-cause mortality

    Time frame: 28-day period following enrollment

Secondary outcomes

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

    Time frame: 28-day period following enrollment

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

    Time frame: 28-day period following enrollment

  3. Duration of ICU stay

    Time frame: 28-day period following enrollment

  4. Duration of mechanical ventilation

    Time frame: 28-day period following enrollment

  5. Total hospitalization days

    Time frame: 28-day period following enrollment

  6. 28-day readmission rate

    Time frame: 28-day period following enrollment

Other outcomes

  1. Multimodal omics analysis

    Time frame: Day 0

Study contacts

Contact information is provided by the study sponsor or research team.

Liang Peng, Doctor

CONTACT

[email protected]

86-020-85959142

Sponsors and collaborators

Lead sponsor

Zhonghao Fang

Other

Collaborators

  • Fifth Affiliated Hospital of Guangzhou Medical University

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2028
First posted
May 5, 2026
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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