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

Respiratory Tract Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06467864
• Other study ID #: FirstNanjingMU
• Status: Recruiting
• Start date: July 1, 2024
• Est. completion date: May 29, 2025

Study information

• Verified date: June 2024
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Wenkui Sun, Dr
• Phone: +86 13914742215
• Email: sunwenkui[@]njmu.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 29, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Aged 18 years and above.

2. Previously relied on mechanical ventilation (endotracheal intubation or tracheotomy) for breathing assistance, and the duration of mechanical ventilation is more than 48h.

3. 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:

1. Bronchoscopy and respiratory specimen collection are not performed at screening (DAY 1) and after 3 days of treatment (DAY 4).

2. Incomplete or missing medical history and refusal by the patient or family to sign the informed consent form for the study.

After completion of the initial screening, a fiberoptic bronchoscopy will be carried out, and BALF is collected for microbiological culture. The results of the culture showed no evidence of infection by study-associated lower respiratory pathogens. [The evidence of infection is defined as a single positive BALF culture (pathogen quantification =10^4cfu/ml or "++" and more) obtained on DAY1. And the study-associated causative pathogens are Pseudomonas aeruginosa, Acinetobacter baumannii, Klebsiella pneumoniae, and Staphylococcus aureus. Additionally, the included patient must have a single infection with one of these pathogens.

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Pneumonia, Ventilator-Associated
• Prognosis
• Respiratory Tract Infections

Intervention

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

Locations

Country	Name	City	State
China	he First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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