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

Официальное название

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

Обзор

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

Вмешательства

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

Первичные конечные точки

• mortality at day 28 [Срок оценки: 28 days after enrollment]

Вторичные конечные точки (2)

• clinical characteristics [Срок оценки: 0 day, 3 days, 7days, 14 days and 28 days after enrollment]
• pathogen [Срок оценки: 0 day, 3 days, 7days, 14 days and 28 days after enrollment]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06028217 · CHAPTER-1.7

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗