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

28. april 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Anslået)

2700

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

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

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
lungebetændelse
Severe pneumonia
Non-infection control group

Hvad måler undersøgelsen?

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Zhonghao Fang

Samarbejdspartnere

Fifth Affiliated Hospital of Guangzhou Medical University

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. maj 2026

Primær færdiggørelse (Anslået)

1. maj 2026

Studieafslutning (Anslået)

28. maj 2028

Datoer for studieregistrering

Først indsendt

28. april 2026

Først indsendt, der opfyldte QC-kriterier

28. april 2026

Først opslået (Faktiske)

5. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • P-2026-001

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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