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NCT Number: NCT06028217

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

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

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

prognosis status

Other

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

Primary outcomes

  1. mortality at day 28

    Time frame: 28 days after enrollment

    prognosis

Secondary outcomes

  1. clinical characteristics

    Time frame: 0 day, 3 days, 7days, 14 days and 28 days after enrollment

    symptoms, physical examinations, comorbidity, laboratory tests, imaging findings and treatment

  2. pathogen

    Time frame: 0 day, 3 days, 7days, 14 days and 28 days after enrollment

    molecular characteristics of responsible pathogen; antibiotic resistance of bacteria

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

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

Acronym: CHAPTER

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Sep 8, 2023
Registry last updated
Sep 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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