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

NCT05270018 | Unknown DMC

• 1 other identifier: STPH-ICU-005
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventilators, Mechanical

Keywords

Ventilators; Bacterial Lysates; Microecology; pneumonia

Outcome Measures

Primary Outcomes (1)

• VAP incidence

  The incidence rate of ventilator associated pneumonia

  2 weeks

Secondary Outcomes (4)

• Assessment of human immune status

  one week

• drug resistant bacteria Incidence

  one week

• Composition of respiratory bacteria

  one week

• survival rate

  28 days

Study Arms (2)

Bacterial Lysate group

EXPERIMENTAL

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

Control group

PLACEBO COMPARATOR

Oral / gastric administration of normal saline once a day, 14.0ml each time

Other: normal saline

Interventions

Bacterial Lysates DRUG

14mg once a day

Also known as: Fan fusu

Bacterial Lysate group

normal saline OTHER

14.0ml once a day

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheng Wang MD PhD: lead

Study Sites (1)

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200072, China

RECRUITING

MeSH Terms

Conditions

Pneumonia

Interventions

Bacterial Lysates; Saline Solution

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Sheng Wang, MD, PhD

CONTACT

862166307174; wangsheng@tongji.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: December 29, 2021
• First Posted: March 8, 2022
• Study Start: March 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: April 1, 2023
• Last Updated: March 8, 2022

Record last verified: 2022-02

Locations

CN (1)