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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThe First Affiliated Hospital with Nanjing Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • bronchoscope

    Procedure/Surgery

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

Treatment groups

No treatment groups listed

Trial outcomes

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.

Time frame
28 day after enrollment

Secondary outcomes

Other outcomes

Sponsors and contacts

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The First Affiliated Hospital with Nanjing Medical University

Lead sponsor

Shanghai East Hospital of Tongji University

Collaborator

First Affiliated Hospital of Wannan Medical College

Collaborator