Actively Recruiting
Predicting Ventilator-associated Lower Respiratory Tract Infection Outcomes Using Sequenced-based Early Microbiological Response: A Multi-center Prospective Study
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2025-05-23
200
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
T
The First Affiliated Hospital with Nanjing Medical University
Lead Sponsor
S
Shanghai East Hospital of Tongji University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying ventilator-associated lower respiratory tract infections, focusing on how changes in local pathogen levels relate to patient outcomes. They are evaluating a tool called QtNGS that measures these pathogens using advanced sequencing techniques. This multi-center prospective study aims to better understand the connection between pathogen abundance before and after treatment and how it affects recovery or complications. Participants will have bronchoscopy procedures to collect lung fluid samples at enrollment and three days after treatment. These samples will help measure pathogen levels using the QtNGS tool. The study does not involve experimental treatments but observes patients who have been on mechanical ventilation and have signs of infection. During the study, participants will undergo bronchoscopy at two time points to collect fluid for analysis. Researchers will track clinical outcomes including mortality within 28 days after enrollment. The study involves careful monitoring of infections by specific bacteria and collects data to assess the relationship between early microbiological changes and patient prognosis over about one month.
CONDITIONS
Brief Title
Predicting Ventilator-associated Lower Respiratory Tract Infection Outcomes Using Sequenced-based Early Microbiological Response
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years and above
- Previously relied on mechanical ventilation (endotracheal intubation or tracheotomy) for breathing assistance for more than 48 hours
- Presence of lower respiratory tract infection based on at least two of the following: abnormal temperature (greater than 38.5�B0C or less than 36.5�B0C), abnormal white blood cell count (greater than 12 x 10^9/L or less than 4 x 10^9/L), and purulent tracheal secretions
You will not qualify if you...
- Bronchoscopy and respiratory specimen collection not performed at screening (Day 1) and after 3 days of treatment (Day 4)
- Patient or family refusal to participate in the study
- No evidence of infection by study-associated pathogens based on bacterial culture from bronchoalveolar lavage fluid at initial screening
- Infection must be with one of the following single pathogens: Pseudomonas aeruginosa, Acinetobacter baumannii, Klebsiella pneumoniae, or Staphylococcus aureus; patients with other infections are excluded
- Evidence of infection defined as single positive bacterial culture with pathogen quantification 210^4 cfu/ml or "++" and above on Day 1
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) including bronchoscopy and respiratory specimen collection
Duration - 4 days
Participants undergo bronchoscopy and bronchoalveolar lavage fluid collection at enrollment and three days after treatment to assess infection status.
2 visits (in-person) on Day 1 and Day 4
Duration - 28 days
Participants are observed for outcomes including 28-day mortality following enrollment.
Follow-up visits as per routine clinical care
Trial Site Locations
Total: 1 location
1
he First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 21000
Actively Recruiting
Research Team
W
Wenkui Sun, Dr
J
Ji Zhou, Dr
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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