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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Hospital-acquired Pneumonia; Antibiotic Resistant Infection
• Intervention / Treatment: Other: prognosis status

• Study Type: Observational
• Enrollment (Estimated): 4000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mortality at day 28	prognosis	28 days after enrollment

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ruijin Hospital

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: August 31, 2023
• First Submitted That Met QC Criteria: August 31, 2023
• First Posted (Actual): September 8, 2023

Study Record Updates

• Last Update Posted (Actual): September 8, 2023
• Last Update Submitted That Met QC Criteria: August 31, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Pneumonia
• Other Study ID Numbers: CHAPTER-1.7

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No