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

Observational Hospital-acquired Pneumonia Antibiotic Resistant Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: prognosis status.
Who it may be relevant to
Registry conditions: Hospital-acquired Pneumonia, Antibiotic Resistant Infection. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

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

Primary outcome measures

  • mortality at day 28 [Time frame: 28 days after enrollment]
Secondary outcome measures (2)
  • clinical characteristics [Time frame: 0 day, 3 days, 7days, 14 days and 28 days after enrollment]
  • pathogen [Time frame: 0 day, 3 days, 7days, 14 days and 28 days after enrollment]

Eligibility criteria

Inclusion criteria

  • Age ≥ 18 years old.
  • 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.
  • 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.
  • obtained informed consent

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06028217 · CHAPTER-1.7

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗