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

Not yet recruiting

• Conditions: Hospital-acquired Pneumonia; Antibiotic Resistant Infection
• Interventions: Other: prognosis status

• Registration Number: NCT06028217
• Lead Sponsor: Ruijin Hospital

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-08
• Study First Submitted: 2023-08-31
• Study First Submitted QC: 2023-08-31
• Last Update Submitted: 2023-08-31
• Study First Posted: 2023-09-08
• Last Update Posted: 2023-09-08
• Study Start: 2023-10-01
• Primary Completion: 2027-09-30
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 4000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
survival group	prognosis status	patients still survive at 28 days
mortality group	prognosis status	patients die within 28 days

Primary Outcome Measures

Name	Time	Method
mortality at day 28	28 days after enrollment	prognosis

Secondary Outcome Measures

Name	Time	Method
pathogen	0 day, 3 days, 7days, 14 days and 28 days after enrollment	molecular characteristics of responsible pathogen; antibiotic resistance of bacteria
clinical characteristics	0 day, 3 days, 7days, 14 days and 28 days after enrollment	symptoms, physical examinations, comorbidity, laboratory tests, imaging findings and treatment