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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Respiratory Tract Infections; Pneumonia, Ventilator-Associated; Prognosis
• Intervention / Treatment: Procedure: bronchoscope

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Wenkui Sun, Dr; Phone Number: +86 13914742215; Email: sunwenkui@njmu.edu.cn
• Study Contact Backup: Name: ji zhou, Dr; Phone Number: +86 13951621810; Email: zhoujinjmu@126.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 21000
      • Recruiting
      • he First Affiliated Hospital of Nanjing Medical University
      • Contact: ji zhou, Dr; Phone Number: +86 13951621810; Email: zhoujinjmu@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population description specifies individuals diagnosed with Va-LRTI (Ventilator-associated Lower Respiratory Tract Infection) who were enrolled based on culture-confirmed pathogens, including Pseudomonas aeruginosa, Acinetobacter baumannii, Klebsiella pneumoniae, and Staphylococcus aureus.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
28-day Mortality Rate	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.	28 day after enrollment

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University
• Collaborators: First Affiliated Hospital of Wannan Medical College; Shanghai East Hospital of Tongji University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 29, 2026

Study Registration Dates

• First Submitted: June 16, 2024
• First Submitted That Met QC Criteria: June 16, 2024
• First Posted (Actual): June 21, 2024

Study Record Updates

• Last Update Posted (Actual): May 23, 2025
• Last Update Submitted That Met QC Criteria: May 22, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Healthcare-Associated Pneumonia; Pathologic Processes; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Pneumonia; Cross Infection; Iatrogenic Disease; Infections; Communicable Diseases; Respiratory Tract Infections; Pneumonia, Ventilator-Associated
• Other Study ID Numbers: 2024-SR-223

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No