Predicting Ventilator-associated Lower Respiratory Tract Infection Outcomes Using Sequenced-based Early Microbiological Response
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: bronchoscope.
- Who it may be relevant to
- Registry conditions: Pneumonia, Ventilator-Associated, Respiratory Tract Infections, Prognosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Predicting Ventilator-associated Lower Respiratory Tract Infection Outcomes Using Sequenced-based Early Microbiological Response: A Multi-center Prospective Study
Overview
We are using a tool called QtNGS (quantitative targeted amplicon-based next-generation sequencing ) to measure the abundance of local pathogens in patients with ventilator-associated lower respiratory tract infections. We hypothesize that changes in pathogen abundance before and after treatment are related to patient outcomes. This study aims to evaluate the effectiveness of the tool by analyzing the changes in pathogen abundance and exploring the relationship between these changes and clinical outcomes.
Interventions
- Procedure bronchoscope
We will perform bronchoscopy and collect bronchoalveolar lavage fluid (BALF) samples at the time of patient enrollment and three days after the treatment.
Primary outcome measures
- 28-day Mortality Rate [Time frame: 28 day after enrollment]
Eligibility criteria
Inclusion criteria
- Aged 18 years and above.
- Previously relied on mechanical ventilation (endotracheal intubation or tracheotomy) for breathing assistance, and the duration of mechanical ventilation was more than 48h.
- Lower respiratory tract infection based on at least two of the followings: abnormal temperature (body temperature greater than 38.5°C or less than 36.5°C), leucocyte count abnormality (leucocyte count greater than 12\*10\^9/L or less than 4\*10\^9/L), and the presence of purulent tracheal secretions.
Exclusion criteria
- Bronchoscopy and respiratory specimen collection were not performed at screening (Day 1) and after 3 days of treatment (Day 4).
- Refusal of patients or families to participate in the study
- After initial screening, bronchoscopy was performed to obtain BALF for bacterial culture. The results of the culture showed no evidence of infection by study-associated lower respiratory pathogens.
Note: The evidence of infection was defined as a single positive bacterial culture (pathogen quantification ≥10\^4 cfu/ml or "++" and more) on Day1. And the study-associated causative pathogens are Pseudomonas aeruginosa, Acinetobacter baumannii, Klebsiella pneumoniae, and Staphylococcus aureus. Additionally, the included patient must have single infection with one of these pathogens.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- he First Affiliated Hospital of Nanjing Medical University — Nanjing
Identifiers
NCT: NCT06467864 · 2024-SR-223