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

Not Applicable

• Conditions: Ventilators, Mechanical
• Interventions: Drug: Bacterial Lysates; Other: normal saline

• Registration Number: NCT05270018
• Lead Sponsor: Sheng Wang MD PhD

Brief Summary

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

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).

Study Timeline

• Study First Submitted: 2021-12-29
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-25
• Last Update Submitted: 2022-02-25
• Study Start: 2022-03-01
• Study First Posted: 2022-03-08
• Last Update Posted: 2022-03-08
• Primary Completion: 2022-12-31
• Study Completion: 2023-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bacterial Lysate group	Bacterial Lysates	Oral / gastric administration of bacterial lysate once a day on an empty stomach, 14.0mg each time for at least 5 days
Control group	normal saline	Oral / gastric administration of normal saline once a day, 14.0ml each time

Primary Outcome Measures

Name	Time	Method
VAP incidence	2 weeks	The incidence rate of ventilator associated pneumonia

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Shanghai Tenth People's Hospital; 🇨🇳 Shanghai, Shanghai, China