- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07567911
A Prospective Observational Cohort Study Protocol for Disease Severity Stratification and Prognosis Assessment in Patients With Pneumonia
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Liang Peng, Doctor
- Telefonnummer: 86-020-85959142
- E-post: pl_206@126.com
Studieorter
-
-
Guangdong
-
Guangzhou, Guangdong, Kina
- Fifth Affiliated Hospital of Guangzhou Medical University
-
Kontakt:
- Liang Peng, Doctor
- Telefonnummer: 86-020-85959142
- E-post: pl_206@126.com
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
|---|
|
lunginflammation
|
|
Severe pneumonia
|
|
Non-infection control group
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
28-day all-cause mortality
Tidsram: 28-day period following enrollment
|
28-day period following enrollment
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
The incidence rate of patients in the non-severe group progressing to severe condition
Tidsram: 28-day period following enrollment
|
28-day period following enrollment
|
|
Time taken for the non-severe group to progress to the severe stage
Tidsram: 28-day period following enrollment
|
28-day period following enrollment
|
|
Duration of ICU stay
Tidsram: 28-day period following enrollment
|
28-day period following enrollment
|
|
Duration of mechanical ventilation
Tidsram: 28-day period following enrollment
|
28-day period following enrollment
|
|
Total hospitalization days
Tidsram: 28-day period following enrollment
|
28-day period following enrollment
|
|
28-day readmission rate
Tidsram: 28-day period following enrollment
|
28-day period following enrollment
|
Andra resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Multimodal omics analysis
Tidsram: Day 0
|
Day 0
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Studiestol: Zifeng Yang, Doctor, The First Affiliated Hospital of Guangzhou Medical University
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- P-2026-001
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Läkemedels- och apparatinformation, studiedokument
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