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

• ClinicalTrials.gov Identifier: NCT06028217
• Recruitment Status: Not yet recruiting
• First Posted: September 8, 2023
• Last Update Posted: September 8, 2023
• Sponsor: Ruijin Hospital
• Information provided by (Responsible Party): Jieming QU, Ruijin Hospital

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

Study Design

• Study Type: Observational
• Estimated 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)
• Estimated Study Start Date: October 1, 2023
• Estimated Primary Completion Date: September 30, 2027
• Estimated Study Completion Date: December 31, 2027

Groups and Cohorts

Group/Cohort	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 [ Time Frame: 28 days after enrollment ]
   prognosis

Secondary Outcome Measures :

1. clinical characteristics [ Time Frame: 0 day, 3 days, 7days, 14 days and 28 days after enrollment ]
   symptoms, physical examinations, comorbidity, laboratory tests, imaging findings and treatment
2. pathogen [ Time Frame: 0 day, 3 days, 7days, 14 days and 28 days after enrollment ]
   molecular characteristics of responsible pathogen; antibiotic resistance of bacteria

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 100 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

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

Criteria

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Jieming QU, Professor, Ruijin Hospital
• ClinicalTrials.gov Identifier: NCT06028217
• Other Study ID Numbers: CHAPTER-1.7
• First Posted: September 8, 2023
• Last Update Posted: September 8, 2023
• Last Verified: August 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Pneumonia; Healthcare-Associated Pneumonia; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Cross Infection; Iatrogenic Disease; Disease Attributes; Pathologic Processes