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

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ClinicalTrials.gov Identifier: NCT05270018
Recruitment Status : Recruiting
First Posted : March 8, 2022
Last Update Posted : March 8, 2022
Sponsor:
Information provided by (Responsible Party):
Sheng Wang MD PhD, Shanghai 10th People's Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Ventilators, Mechanical Drug: Bacterial Lysates Other: normal saline Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : March 1, 2022
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : April 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arms and Interventions
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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 Name: 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


Outcome Measures
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Primary Outcome Measures :
  1. VAP incidence [ Time Frame: 2 weeks ]
    The incidence rate of ventilator associated pneumonia


Secondary Outcome Measures :
  1. 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

  2. drug resistant bacteria Incidence [ Time Frame: one week ]
    The incidence rate of drug resistant bacteria

  3. Composition of respiratory bacteria [ Time Frame: one week ]
    probiotics and pathogens via NGS analysis

  4. survival rate [ Time Frame: 28 days ]
    ICU in-hospital mortality and 28 day mortality


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05270018


Contacts
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Contact: Sheng Wang, MD, PhD 862166307174 wangsheng@tongji.edu.cn

Locations
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China, Shanghai
Shanghai Tenth People's Hospital Recruiting
Shanghai, Shanghai, China, 200072
Contact: Qixing Wang, MSc    86-21-66307153    wangqixing1221@163.com   
Principal Investigator: Sheng Wang, MD, PhD         
Sponsors and Collaborators
Sheng Wang MD PhD
More Information
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Responsible Party: Sheng Wang MD PhD, Director, Shanghai 10th People's Hospital
ClinicalTrials.gov Identifier: NCT05270018    
Other Study ID Numbers: STPH-ICU-005
First Posted: March 8, 2022    Key Record Dates
Last Update Posted: March 8, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sheng Wang MD PhD, Shanghai 10th People's Hospital:
Ventilators; Bacterial Lysates; Microecology; pneumonia
Additional relevant MeSH terms:
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Broncho-Vaxom
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs