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

Sponsor
Sheng Wang MD PhD (Other)
Overall Status
Recruiting
CT.gov ID
NCT05270018
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
13
Anticipated Duration (Months)
7.7
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: Bacterial Lysates
  • Other: normal saline
 N/A

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

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
Mar 1, 2022
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Apr 1, 2023

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. VAP incidence [2 weeks]

      The incidence rate of ventilator associated pneumonia

    Secondary Outcome Measures

    1. 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

    2. drug resistant bacteria Incidence [one week]

      The incidence rate of drug resistant bacteria

    3. Composition of respiratory bacteria [one week]

      probiotics and pathogens via NGS analysis

    4. survival rate [28 days]

      ICU in-hospital mortality and 28 day mortality

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Shanghai Tenth People's Hospital Shanghai Shanghai China 200072

    Sponsors and Collaborators

    • Sheng Wang MD PhD

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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:
    Mar 8, 2022
    Last Update Posted:
    Mar 8, 2022
    Last Verified:
    Feb 1, 2022
    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, Director, Shanghai 10th People's Hospital
    Ventilators; Bacterial Lysates; Microecology; pneumonia
    Additional relevant MeSH terms:
    Broncho-Vaxom

    Study Results

    No Results Posted as of Mar 8, 2022