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

Antibiotic Resistant Infection Clinical Trial

— CHAPTER  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06028217
• Other study ID #: CHAPTER-1.7
• Status: Not yet recruiting
• Start date: October 1, 2023
• Est. completion date: December 31, 2027

Study information

• Verified date: August 2023
• Source: Ruijin Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 4000
• Est. completion date: December 31, 2027
• Est. primary completion date: September 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Antibiotic Resistant Infection
• Healthcare-Associated Pneumonia
• Hospital-acquired Pneumonia
• Pneumonia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mortality at day 28	prognosis	28 days after enrollment
Secondary	clinical characteristics	symptoms, physical examinations, comorbidity, laboratory tests, imaging findings and treatment	0 day, 3 days, 7days, 14 days and 28 days after enrollment
Secondary	pathogen	molecular characteristics of responsible pathogen; antibiotic resistance of bacteria	0 day, 3 days, 7days, 14 days and 28 days after enrollment