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

Sponsor
Ruijin Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06028217
Collaborator
(none)
4,000
51

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Other: prognosis status

Study Design

Study Type:
Observational
Anticipated Enrollment :
4000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Prospective Study on Pathogen Investigation, Risk Factors, and Prognostic Factors Analysis of Hospital Acquired Pneumonia (HAP)
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Sep 30, 2027
Anticipated Study Completion Date :
Dec 31, 2027

Arms and Interventions

Arm Intervention/Treatment
survival group

patients still survive at 28 days

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

mortality group

patients die within 28 days

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

Outcome Measures

Primary Outcome Measures

  1. mortality at day 28 [28 days after enrollment]

    prognosis

Secondary Outcome Measures

  1. clinical characteristics [0 day, 3 days, 7days, 14 days and 28 days after enrollment]

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

  2. pathogen [0 day, 3 days, 7days, 14 days and 28 days after enrollment]

    molecular characteristics of responsible pathogen; antibiotic resistance of bacteria

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 × 109/L or <4 × 109/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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Ruijin Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jieming QU, Professor, Ruijin Hospital
ClinicalTrials.gov Identifier:
NCT06028217
Other Study ID Numbers:
  • CHAPTER-1.7
First Posted:
Sep 8, 2023
Last Update Posted:
Sep 8, 2023
Last Verified:
Aug 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 8, 2023