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

NCT06028217 | Not Yet Recruiting

• 1 other identifier: CHAPTER-1.7
• Study Type: observational
• Target: 4,000
• Locations: 0 countries
• Sites: N/A

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. 1.clarify the regional differences and changes over time in the pathogen spectrum and antibiotic resistance rate among HAP patients in China;
2. 2.build a continuously optimized nationwide HAP pathogen and antibiotic resistance surveillance network;
3. 3.identify the molecular epidemiology of common pathogens

Conditions

Hospital-acquired Pneumonia; Antibiotic Resistant Infection

Outcome Measures

Primary Outcomes (1)

• mortality at day 28

  prognosis

  28 days after enrollment

Secondary Outcomes (2)

• clinical characteristics

  0 day, 3 days, 7days, 14 days and 28 days after enrollment

• pathogen

  0 day, 3 days, 7days, 14 days and 28 days after enrollment

Study Arms (2)

survival group

patients still survive at 28 days

Other: prognosis status

mortality group

patients die within 28 days

Other: prognosis status

Interventions

prognosis status OTHER

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

mortality group; survival group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

hospital-acquired pneumonia adult patients with qualified evidence of responsible pathogen in China

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead

MeSH Terms

Conditions

Healthcare-Associated Pneumonia

Condition Hierarchy (Ancestors)

Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: September 8, 2023
• Study Start: October 1, 2023
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 8, 2023

Record last verified: 2023-08