Ventilators, MechanicalNCT05270018
Bacterial Lysates on Respiratory Tract Microecology and Evaluation of the Efficacy of Prevention and Treatment of VAP
A study testing Bacterial Lysates and normal saline in people with Ventilators, Mechanical, run by Sheng Wang MD PhD at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ventilators, Mechanical
- What is being tested?
- Bacterial Lysates and normal saline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2022to 1 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200072
Qixing Wang, MSc, 86-21-66307153, wangqixing1221@163.com
Sheng Wang, MD, PhD
About this study
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
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.
Read the 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).
- Conditions
- Ventilators, Mechanical
- Being tested
- Bacterial Lysates, normal saline
- Keywords
- Ventilators; Bacterial Lysates; Microecology; pneumonia
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bacterial LysatesDrug
Also called Fan fusu
14mg once a day
normal salineOther
14.0ml once a day
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Bacterial Lysates |
| Control group | Placebo comparator | Oral / gastric administration of normal saline once a day, 14.0ml each time Receives: Other: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAP incidence
The incidence rate of ventilator associated pneumonia
Measured: 2 weeks
Secondary outcomes (4)
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
Measured: one week
drug resistant bacteria Incidence
The incidence rate of drug resistant bacteria
Measured: one week
Composition of respiratory bacteria
probiotics and pathogens via NGS analysis
Measured: one week
survival rate
ICU in-hospital mortality and 28 day mortality
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start1 Mar 2022 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilators, MechanicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheng Wang MD PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sheng Wang MD PhD, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05270018
- Sponsor's protocol ID
- STPH-ICU-005
- Status last verified
- Feb 2022
- First submitted
- 29 Dec 2021
- Last updated
- 8 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05270018
- Acronym / sponsor ID
- STPH-ICU-005
- Conditions
- Ventilators, Mechanical
- Keywords
- Ventilators; Bacterial Lysates; Microecology; pneumonia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sheng Wang MD PhDUniversity, hospital or other
- Study start
- 1 Mar 2022 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 8 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bacterial Lysate group | Experimental | Drug: Bacterial LysatesOral / gastric administration of bacterial lysate once a day on an empty stomach, 14.0mg each time for at least 5 days |
| Control group | Placebo comparator | Other: normal salineOral / gastric administration of normal saline once a day, 14.0ml each time |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bacterial LysatesAlso: Fan fusu14mg once a day | Drug | Bacterial Lysate group |
| normal saline14.0ml once a day | Other | Control group |
Primary outcome
VAP incidence
Time frame: 2 weeks
The incidence rate of ventilator associated pneumonia
4 secondary outcomes
Assessment of human immune status
Time frame: one week
drug resistant bacteria Incidence
Time frame: one week
Composition of respiratory bacteria
Time frame: one week
survival rate
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bacterial Lysates and normal saline in people with Ventilators, Mechanical, run by Sheng Wang MD PhD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sheng Wang, MD, PhD (862166307174, wangsheng@tongji.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAP incidence (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2022.