- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07567911
A Prospective Observational Cohort Study Protocol for Disease Severity Stratification and Prognosis Assessment in Patients With Pneumonia
Studieoversikt
Status
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Liang Peng, Doctor
- Telefonnummer: 86-020-85959142
- E-post: pl_206@126.com
Studiesteder
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Guangdong
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Guangzhou, Guangdong, Kina
- Fifth Affiliated Hospital of Guangzhou Medical University
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Ta kontakt med:
- Liang Peng, Doctor
- Telefonnummer: 86-020-85959142
- E-post: pl_206@126.com
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
- 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
- End-stage diseases (such as expected survival < 48 hours);
- Long-term immunosuppressive therapy;
- Pregnant or lactating women;
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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lungebetennelse
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Severe pneumonia
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Non-infection control group
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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28-day all-cause mortality
Tidsramme: 28-day period following enrollment
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28-day period following enrollment
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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The incidence rate of patients in the non-severe group progressing to severe condition
Tidsramme: 28-day period following enrollment
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28-day period following enrollment
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Time taken for the non-severe group to progress to the severe stage
Tidsramme: 28-day period following enrollment
|
28-day period following enrollment
|
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Duration of ICU stay
Tidsramme: 28-day period following enrollment
|
28-day period following enrollment
|
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Duration of mechanical ventilation
Tidsramme: 28-day period following enrollment
|
28-day period following enrollment
|
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Total hospitalization days
Tidsramme: 28-day period following enrollment
|
28-day period following enrollment
|
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28-day readmission rate
Tidsramme: 28-day period following enrollment
|
28-day period following enrollment
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Andre resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Multimodal omics analysis
Tidsramme: Day 0
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Day 0
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Studiestol: Zifeng Yang, Doctor, The First Affiliated Hospital of Guangzhou Medical University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- P-2026-001
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Legemiddel- og utstyrsinformasjon, studiedokumenter
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