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

NCT06467864 | Recruiting

• 1 other identifier: 2024-SR-223
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pneumonia, Ventilator-Associated; Respiratory Tract Infections; Prognosis

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

bronchoscope PROCEDURE

We will perform bronchoscopy and collect bronchoalveolar lavage fluid (BALF) samples at the time of patient enrollment and three days after the treatment.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead
• Shanghai East Hospital of Tongji University: collaborator
• First Affiliated Hospital of Wannan Medical College: collaborator

Study Sites (1)

he First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 21000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

We will perform bronchoscopy and collect bronchoalveolar lavage fluid (BALF) samples at the time of patient enrollment and three days after the treatment

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated; Respiratory Tract Infections

Interventions

Bronchoscopes

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopes; Diagnostic Equipment; Equipment and Supplies; Surgical Equipment

Central Study Contacts

Wenkui Sun, Dr

CONTACT

+86 13914742215; sunwenkui@njmu.edu.cn

Ji Zhou, Dr

CONTACT

+86 13951621810; zhoujinjmu@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 28 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2024
• First Posted: June 21, 2024
• Study Start: April 1, 2024
• Primary Completion: January 1, 2026
• Study Completion: January 29, 2026
• Last Updated: May 23, 2025

Record last verified: 2025-05

Locations

CN (1)