Bacterial Lysates on Respiratory Tract Microecology and Evaluation of the Efficacy of Prevention and Treatment of VAP

Study Overview
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Brief Summary
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The purpose of this study is to assess the effect of bacterial lysates on respiratory tract microecology in patients with mechanical ventilation and the efficacy of prevention and treatment of ventilator associated pneumonia.

Detailed Description
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After being informed about the study and potential risks, all patients giving written informed consent will undergo a one-week screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be randomized in a double-blind manner in a 1:1 ratio to Bacterial Lysates( 14mg, once a day) or placebo(once a day).

Official Title
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Effect of Bacterial Lysates on Respiratory Tract Microecology in Patients With Mechanical Ventilation and Evaluation of the Efficacy of Prevention and Treatment of Ventilator-associated Pneumonia

Conditions
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Ventilators, Mechanical

Intervention / Treatment
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* Drug: Bacterial Lysates
* Other: normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients admitted to ICU for mechanical ventilation The expected mechanical ventilation time is more than 72h Sign the informed consent form when conscious and voluntary, and complete the questionnaire survey and follow-up as required; If it is unable to sign the informed consent form and complete the questionnaire survey and follow-up, the legal representative or guardian can act on behalf of it. Exclusion Criteria: Ventilator associated pneumonia is known and confirmed Pregnant or lactating female Allergic to the active ingredients of bacterial lysates or any excipients listed in the ingredients Patients with autoimmune diseases Patients with acute intestinal infection Patients participating in other clinical studies at the same time Patients considered unsuitable by other researchers to participate in this study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bacterial Lysate group<br>Oral / gastric administration of bacterial lysate once a day on an empty stomach, 14.0mg each time for at least 5 days | Drug: Bacterial Lysates<br>* 14mg once a day<br>* Other names: Fan fusu;|
| Placebo Comparator: Control group<br>Oral / gastric administration of normal saline once a day, 14.0ml each time | Other: normal saline<br>* 14.0ml once a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAP incidence | The incidence rate of ventilator associated pneumonia | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of human immune status | Immune status Assessment of IgG, IgA, and IgM levels Quantifications of IgG, IgA, and IgM levels were determined by Immunological Turbidity Kits | one week | 
| drug resistant bacteria Incidence | The incidence rate of drug resistant bacteria | one week | 
| Composition of respiratory bacteria | probiotics and pathogens via NGS analysis | one week | 
| survival rate | ICU in-hospital mortality and 28 day mortality | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ventilators; Bacterial Lysates; Microecology; pneumonia