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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05270018
Recruitment Status : Unknown
Verified February 2022 by Sheng Wang MD PhD, Shanghai 10th People's Hospital.
Recruitment status was:  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

Tracking Information
First Submitted Date  ICMJE December 29, 2021
First Posted Date  ICMJE March 8, 2022
Last Update Posted Date March 8, 2022
Estimated Study Start Date  ICMJE March 1, 2022
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2022)
VAP incidence [ Time Frame: 2 weeks ]
The incidence rate of ventilator associated pneumonia
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 25, 2022)
  • 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
  • drug resistant bacteria Incidence [ Time Frame: one week ]
    The incidence rate of drug resistant bacteria
  • Composition of respiratory bacteria [ Time Frame: one week ]
    probiotics and pathogens via NGS analysis
  • survival rate [ Time Frame: 28 days ]
    ICU in-hospital mortality and 28 day mortality
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bacterial Lysates on Respiratory Tract Microecology and Evaluation of the Efficacy of Prevention and Treatment of VAP
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Ventilators, Mechanical
Intervention  ICMJE
  • Drug: Bacterial Lysates
    14mg once a day
    Other Name: Fan fusu
  • Other: normal saline
    14.0ml once a day
Study Arms  ICMJE
  • 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
    Intervention: Drug: Bacterial Lysates
  • Placebo Comparator: Control group
    Oral / gastric administration of normal saline once a day, 14.0ml each time
    Intervention: Other: normal saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 25, 2022)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 1, 2023
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05270018
Other Study ID Numbers  ICMJE STPH-ICU-005
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Sheng Wang MD PhD, Shanghai 10th People's Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Sheng Wang MD PhD
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Shanghai 10th People's Hospital
Verification Date February 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP