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

S

Sheng Wang MD PhD

Status

Unknown

Conditions

Ventilators, Mechanical

Treatments

Drug: Bacterial Lysates
Other: normal saline

Study type

Interventional

Funder types

Other

Identifiers

NCT05270018
STPH-ICU-005

Details and patient eligibility

About

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.

Full 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).

Enrollment

100 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

100 participants in 2 patient groups, including a placebo group

Bacterial Lysate group
Experimental group
Description:
Oral / gastric administration of bacterial lysate once a day on an empty stomach, 14.0mg each time for at least 5 days
Treatment:
Drug: Bacterial Lysates
Control group
Placebo Comparator group
Description:
Oral / gastric administration of normal saline once a day, 14.0ml each time
Treatment:
Other: normal saline

Trial contacts and locations

1

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Central trial contact

Sheng Wang, MD, PhD

Data sourced from clinicaltrials.gov

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