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

February 25, 2022 updated by: Sheng Wang MD PhD

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200072
        • Recruiting
        • Shanghai Tenth People's Hospital
        • Contact:
        • Principal Investigator:
          • Sheng Wang, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bacterial Lysate group
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
14mg once a day
Other Names:
  • Fan fusu
Placebo Comparator: Control group
Oral / gastric administration of normal saline once a day, 14.0ml each time
Other: normal saline
14.0ml once a day

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of human immune status
Time Frame: one week
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
Time Frame: one week
The incidence rate of drug resistant bacteria
one week
Composition of respiratory bacteria
Time Frame: one week
probiotics and pathogens via NGS analysis
one week
survival rate
Time Frame: 28 days
ICU in-hospital mortality and 28 day mortality
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheng Wang MD PhD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2022

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

April 1, 2023

Study Registration Dates

First Submitted

December 29, 2021

First Submitted That Met QC Criteria

February 25, 2022

First Posted (Actual)

March 8, 2022

Study Record Updates

Last Update Posted (Actual)

March 8, 2022

Last Update Submitted That Met QC Criteria

February 25, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STPH-ICU-005

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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