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

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

Tracking Information

• First Submitted Date: December 29, 2021
• First Posted Date: March 8, 2022
• Last Update Posted Date: March 8, 2022
• Estimated Study Start Date: March 1, 2022
• Estimated Primary Completion Date: December 31, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 25, 2022)

VAP incidence [ Time Frame: 2 weeks ]

The incidence rate of ventilator associated pneumonia

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Bacterial Lysates on Respiratory Tract Microecology and Evaluation of the Efficacy of Prevention and Treatment of VAP
• 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
• 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Ventilators, Mechanical

Intervention

• Drug: Bacterial Lysates
  14mg once a day
  Other Name: Fan fusu
• Other: normal saline
  14.0ml once a day

Study Arms

• 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

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: February 25, 2022): 100
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 1, 2023
• Estimated Primary Completion Date: December 31, 2022 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT05270018
• Other Study ID Numbers: 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: Not Provided
• Current Responsible Party: Sheng Wang MD PhD, Shanghai 10th People's Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Sheng Wang MD PhD
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Shanghai 10th People's Hospital
• Verification Date: February 2022