Hospital-acquired PneumoniaCHAPTERNCT06028217
Chinese Hospital Acquired Pneumonia Collaboration Network: Epidemiology, Diagnosis and Treatment
An observational study of Hospital-acquired Pneumonia and Antibiotic Resistant Infection, run by Ruijin Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Hospital-acquired Pneumonia, Antibiotic Resistant Infection
- What is being tested?
- prognosis status
- How many people
- 4,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2023to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: hospital-acquired pneumonia adult patients with qualified evidence of responsible pathogen in China
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: 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:
- 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
- Being tested
- prognosis status
- Medical subject headings
- Healthcare-Associated Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prognosis statusOther
observatory; patients will be divided into survival group and mortality group according to their prognosis at day 28
| Study group | Role | What they receive |
|---|---|---|
| survival group | patients still survive at 28 days Receives: Other: prognosis status | |
| mortality group | patients die within 28 days Receives: Other: prognosis status |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality at day 28
prognosis
Measured: 28 days after enrollment
Secondary outcomes (2)
clinical characteristics
symptoms, physical examinations, comorbidity, laboratory tests, imaging findings and treatment
Measured: 0 day, 3 days, 7days, 14 days and 28 days after enrollment
pathogen
molecular characteristics of responsible pathogen; antibiotic resistance of bacteria
Measured: 0 day, 3 days, 7days, 14 days and 28 days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start1 Oct 2023 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hospital-acquired PneumoniaStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jieming QU, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06028217
- Sponsor's protocol ID
- CHAPTER-1.7
- Acronym
- CHAPTER
- Status last verified
- Aug 2023
- First submitted
- 31 Aug 2023
- Last updated
- 8 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study on Pathogen Investigation, Risk Factors, and Prognostic Factors Analysis of Hospital Acquired Pneumonia (HAP)
- ClinicalTrials.gov ID
- NCT06028217
- Acronym / sponsor ID
- CHAPTER / CHAPTER-1.7
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 8 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| survival group | – | Other: prognosis statuspatients still survive at 28 days |
| mortality group | – | Other: prognosis statuspatients die within 28 days |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- hospital-acquired pneumonia adult patients with qualified evidence of responsible pathogen in China
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prognosis statusobservatory; patients will be divided into survival group and mortality group according to their prognosis at day 28 | Other | mortality group, survival group |
Primary outcome
mortality at day 28
Time frame: 28 days after enrollment
prognosis
2 secondary outcomes
clinical characteristics
Time frame: 0 day, 3 days, 7days, 14 days and 28 days after enrollment
pathogen
Time frame: 0 day, 3 days, 7days, 14 days and 28 days after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hospital-acquired Pneumonia and Antibiotic Resistant Infection, run by Ruijin Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality at day 28 (time frame: 28 days after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2023.