Chinese Hospital Acquired Pneumonia Collaboration Network: Epidemiology, Diagnosis and Treatment (CHAPTER)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT06028217 |
Recruitment Status :
Not yet recruiting
First Posted : September 8, 2023
Last Update Posted : September 8, 2023
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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:
- clarify the regional differences and changes over time in the pathogen spectrum and antibiotic resistance rate among HAP patients in China;
- build a continuously optimized nationwide HAP pathogen and antibiotic resistance surveillance network;
- identify the molecular epidemiology of common pathogens
Condition or disease | Intervention/treatment |
---|---|
Hospital-acquired Pneumonia Antibiotic Resistant Infection | Other: prognosis status |
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 |
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 |
- mortality at day 28 [ Time Frame: 28 days after enrollment ]prognosis
- 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
- pathogen [ Time Frame: 0 day, 3 days, 7days, 14 days and 28 days after enrollment ]molecular characteristics of responsible pathogen; antibiotic resistance of bacteria
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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 |
Inclusion Criteria:
- Age ≥ 18 years old.
- 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.
- 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.
- obtained informed consent
Exclusion Criteria:
- Those who cannot understand and execute the investigation plan.
- Active pulmonary tuberculosis;
- Severely immunosuppressed patients: absolute neutrophil count <0.5× 10^9/L, CD4<200/ml.
Responsible Party: | Jieming QU, Professor, Ruijin Hospital |
ClinicalTrials.gov Identifier: | NCT06028217 |
Other Study ID Numbers: |
CHAPTER-1.7 |
First Posted: | September 8, 2023 Key Record Dates |
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 |
Pneumonia Healthcare-Associated Pneumonia Respiratory Tract Infections Infections Lung Diseases |
Respiratory Tract Diseases Cross Infection Iatrogenic Disease Disease Attributes Pathologic Processes |