Predicting Ventilator-associated Lower Respiratory Tract Infection Outcomes Using Sequenced-based Early Microbiological Response

Launched by THE FIRST AFFILIATED HOSPITAL WITH NANJING MEDICAL UNIVERSITY · Jun 16, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new method to understand how certain germs, known as pathogens, affect patients with pneumonia who are on ventilators. Researchers are using a special tool called QtNGS to see how the amount of these germs changes before and after treatment. They believe that these changes can help predict how well patients will recover from their infections.

To join this study, participants need to be 18 years or older and have been on a ventilator for more than two days due to a lower respiratory infection. The trial is looking for patients who show specific signs of infection, such as an abnormal body temperature or unusual white blood cell counts. If you decide to participate, you will undergo tests to understand your infection better and help researchers learn more about how to improve treatment for future patients. Remember, your participation is completely voluntary, and your health and comfort are the top priority throughout the study.

Gender

ALL

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.