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

Ventilators, Mechanical Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05270018
• Other study ID #: STPH-ICU-005
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: April 1, 2023

Study information

• Verified date: February 2022
• Source: Shanghai 10th People's Hospital
• Contact: Sheng Wang, MD, PhD
• Phone: 862166307174
• Email: wangsheng[@]tongji.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 1, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Ventilators, Mechanical

Intervention

Drug:
• Bacterial Lysates
14mg once a day

Other:
• normal saline
14.0ml once a day

Locations

Country	Name	City	State
China	Shanghai Tenth People's Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Sheng Wang MD PhD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAP incidence	The incidence rate of ventilator associated pneumonia	2 weeks
Secondary	Assessment of human immune status	Immune status Assessment of IgG, IgA, and IgM levels Quantifications of IgG, IgA, and IgM levels were determined by Immunological Turbidity Kits	one week
Secondary	drug resistant bacteria Incidence	The incidence rate of drug resistant bacteria	one week
Secondary	Composition of respiratory bacteria	probiotics and pathogens via NGS analysis	one week
Secondary	survival rate	ICU in-hospital mortality and 28 day mortality	28 days