Predicting Ventilator-associated Lower Respiratory Tract Infection Outcomes Using Sequenced-based Early Microbiological Response: A Multi-center Prospective Study

Recruiting

• Conditions: Pneumonia, Ventilator-Associated; Respiratory Tract Infections; Prognosis

• Registration Number: NCT06467864
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Brief Summary

We are using a tool called QtNGS 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-01
• Study First Submitted: 2024-06-16
• Study First Submitted QC: 2024-06-16
• Study First Posted: 2024-06-21
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-13
• Last Update Posted: 2024-11-15
• Primary Completion: 2025-05-01
• Study Completion: 2025-05-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
28-day Mortality Rate	28 day after enrollment	The 28-day mortality rate will be measured to determine the percentage of patients who die within 28 days of study enrollment. This outcome will help assess the effectiveness of QtNGS in evaluating early microbiological response.

Trial Locations

Locations (1)

he First Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China