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

28. april 2026 oppdatert av: Zhonghao Fang
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.

Studieoversikt

Status

Har ikke rekruttert ennå

Studietype

Observasjonsmessig

Registrering (Antatt)

2700

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Liang Peng, Doctor
  • Telefonnummer: 86-020-85959142
  • E-post: pl_206@126.com

Studiesteder

    • Guangdong
      • Guangzhou, Guangdong, Kina
        • Fifth Affiliated Hospital of Guangzhou Medical University
        • Ta kontakt med:
          • Liang Peng, Doctor
          • Telefonnummer: 86-020-85959142
          • E-post: pl_206@126.com

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

  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;

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
lungebetennelse
Severe pneumonia
Non-infection control group

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
28-day all-cause mortality
Tidsramme: 28-day period following enrollment
28-day period following enrollment

Sekundære resultatmål

Resultatmål
Tidsramme
The incidence rate of patients in the non-severe group progressing to severe condition
Tidsramme: 28-day period following enrollment
28-day period following enrollment
Time taken for the non-severe group to progress to the severe stage
Tidsramme: 28-day period following enrollment
28-day period following enrollment
Duration of ICU stay
Tidsramme: 28-day period following enrollment
28-day period following enrollment
Duration of mechanical ventilation
Tidsramme: 28-day period following enrollment
28-day period following enrollment
Total hospitalization days
Tidsramme: 28-day period following enrollment
28-day period following enrollment
28-day readmission rate
Tidsramme: 28-day period following enrollment
28-day period following enrollment

Andre resultatmål

Resultatmål
Tidsramme
Multimodal omics analysis
Tidsramme: Day 0
Day 0

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Etterforskere

  • Studiestol: Zifeng Yang, Doctor, The First Affiliated Hospital of Guangzhou Medical University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. mai 2026

Primær fullføring (Antatt)

1. mai 2026

Studiet fullført (Antatt)

28. mai 2028

Datoer for studieregistrering

Først innsendt

28. april 2026

Først innsendt som oppfylte QC-kriteriene

28. april 2026

Først lagt ut (Faktiske)

5. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. april 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • P-2026-001

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Due to concerns over patient privacy and confidentiality issues, the individual patient data (IPD) may not be shared.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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