Using sequencing to predict outcomes of pneumonia in ventilated patients
Predicting Ventilator-associated Lower Respiratory Tract Infection Outcomes Using Sequenced-based Early Microbiological Response: A Multi-center Prospective Study
This study is testing if analyzing germs in the lungs of patients on ventilators can help predict how well they will recover from pneumonia.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT06467864 on ClinicalTrials.gov |
What this trial studies
This observational study utilizes a tool called QtNGS to analyze the abundance of pathogens in patients suffering from ventilator-associated lower respiratory tract infections. By measuring changes in pathogen levels before and after treatment, the study aims to establish a correlation between these changes and patient outcomes. The research involves bronchoscopy to collect respiratory specimens for analysis, focusing on patients who have been on mechanical ventilation for over 48 hours and exhibit signs of infection.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have been on mechanical ventilation for more than 48 hours and show signs of lower respiratory tract infection.
Not a fit: Patients who do not have evidence of infection by study-associated lower respiratory pathogens or refuse participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prognostic tools for managing pneumonia in mechanically ventilated patients.
How similar studies have performed: While similar approaches using sequencing technologies have shown promise in other contexts, this specific application in ventilator-associated infections is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Nanjing, Jiangsu
- he First Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Wenkui Sun, Dr
- Email: sunwenkui@njmu.edu.cn
- Phone: +86 13914742215
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.