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NCT Number: NCT06467864

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

he First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 21000, China

Location status: Recruiting

Location contact

ji zhou, Dr

CONTACT

[email protected]

+86 13951621810

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 28-day Mortality Rate

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ji Zhou, Dr

CONTACT

[email protected]

+86 13951621810

Wenkui Sun, Dr

CONTACT

[email protected]

+86 13914742215

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Collaborators

  • First Affiliated Hospital of Wannan Medical College
  • Shanghai East Hospital of Tongji University

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 21, 2024
Registry last updated
May 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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