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Not yet recruitingNCT06028217CHAPTERUpdated Sep 8, 2023

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

An observational study in Hospital-acquired Pneumonia and Antibiotic Resistant Infection, sponsored by Ruijin Hospital. Not yet recruiting. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-09-08.

Sponsored by Ruijin Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
4,000
Ages
18 Years to 100 Years
Sex
All
01

Study 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
02

Conditions studied

  • Hospital-acquired Pneumonia
  • Antibiotic Resistant Infection
03

In context

Pneumonia

2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.

This study's planned enrollment of 4,000 is above the median of 203 across 688 observational studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

Ruijin Hospital is the lead sponsor of 635 studies on the registry; 359 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
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

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
4,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • survival group

    patients still survive at 28 days

    Other: prognosis status

  • mortality group

    patients die within 28 days

    Other: prognosis status

Interventions

  • Otherprognosis status

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

06

What researchers measure

Primary outcomes

  1. mortality at day 28

    prognosis

    Time frame: 28 days after enrollment

Secondary outcomes

  1. clinical characteristics

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

    Time frame: 0 day, 3 days, 7days, 14 days and 28 days after enrollment

  2. pathogen

    molecular characteristics of responsible pathogen; antibiotic resistance of bacteria

    Time frame: 0 day, 3 days, 7days, 14 days and 28 days after enrollment

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06028217
Lead sponsor
Ruijin Hospital
Responsible party
Jieming QU (Professor, Ruijin Hospital) — Principal investigator
First posted
Sep 8, 2023
Start date
Oct 1, 2023 (estimated)
Primary completion
Sep 30, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Sep 8, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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