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Chinese Hospital Acquired Pneumonia Collaboration Network: Epidemiology, Diagnosis and Treatment

A Prospective Study on Pathogen Investigation, Risk Factors, and Prognostic Factors Analysis of Hospital Acquired Pneumonia (HAP)

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06028217
Acronym
CHAPTER
Enrollment
4000
Registered
2023-09-08
Start date
2023-10-01
Completion date
2027-12-31
Last updated
2023-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antibiotic Resistant Infection, Hospital-acquired Pneumonia

Brief summary

The goal of this prospective and observatory study is to learn about the pathogen, clinical manifestations, prognosis, treatment and antibiotic resistance of bacteria in hospital-acquired pneumonia patients in China. The main purposes of this study are: 1. clarify the regional differences and changes over time in the pathogen spectrum and antibiotic resistance rate among HAP patients in China; 2. build a continuously optimized nationwide HAP pathogen and antibiotic resistance surveillance network; 3. identify the molecular epidemiology of common pathogens

Interventions

OTHERprognosis status

observatory; patients will be divided into survival group and mortality group according to their prognosis at day 28

Sponsors

Ruijin Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

1. Age ≥ 18 years old. 2. Meets the clinical diagnostic criteria for HAP in the 2018 HAP/VAP guidelines. Chest X-ray or CT shows new or progressive infiltrative shadows, consolidation shadows, or ground glass shadows, combined with 2 or more of the following 3 clinical symptoms, to establish a clinical diagnosis: 1) Fever, body temperature\>38 ℃; 2) Purulent airway secretions; 3) Peripheral blood white blood cell count \>10 × 10\^9/L or \<4 × 10\^9/L. 3. Having qualified evidence of responsible pathogen. On the basis of clinical diagnosis, one of the following conditions should be met simultaneously: 1) Qualified lower respiratory tract secretions (neutrophil count \>25/low magnification field, epithelial cell count \<10/low magnification field, or a ratio of the two \>2.5:1), pathogenic bacteria cultured through bronchoscopy anti pollution brush (PSB), bronchoalveolar lavage fluid (BALF), lung tissue or sterile body fluid, and consistent with clinical manifestations; 2) Pathology, cytopathology, or direct microscopic examination of lung tissue specimens showing fungi and evidence of tissue damage; 3) The serum IgM antibodies of atypical pathogens or viruses change from negative to positive, or the titers of specific IgG antibodies in both acute and recovery phases show a 4-fold or more change. During the outbreak of respiratory viruses and with a history of epidemiological contact, respiratory secretions were tested positive for corresponding virus antigens, nucleic acid tests, or virus culture. 4. obtained informed consent

Exclusion criteria

1. Those who cannot understand and execute the investigation plan. 2. Active pulmonary tuberculosis; 3. Severely immunosuppressed patients: absolute neutrophil count \<0.5× 10\^9/L, CD4\<200/ml.

Design outcomes

Primary

MeasureTime frameDescription
mortality at day 2828 days after enrollmentprognosis

Secondary

MeasureTime frameDescription
clinical characteristics0 day, 3 days, 7days, 14 days and 28 days after enrollmentsymptoms, physical examinations, comorbidity, laboratory tests, imaging findings and treatment
pathogen0 day, 3 days, 7days, 14 days and 28 days after enrollmentmolecular characteristics of responsible pathogen; antibiotic resistance of bacteria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026