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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Control group | Placebo Comparator | Oral / gastric administration of normal saline once a day, 14.0ml each time |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bacterial Lysates | Drug | 14mg once a day |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| VAP incidence | The incidence rate of ventilator associated pneumonia | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| drug resistant bacteria Incidence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sheng Wang, MD, PhD | Contact | 862166307174 | wangsheng@tongji.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Tenth People's Hospital | Recruiting | Shanghai | Shanghai Municipality | 200072 | China |
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| ID | Term |
|---|---|
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000095983 | Bacterial Lysates |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
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| normal saline | Other | 14.0ml once a day |
|
The incidence rate of drug resistant bacteria
| one week |
| Composition of respiratory bacteria | probiotics and pathogens via NGS analysis | one week |
| survival rate | ICU in-hospital mortality and 28 day mortality | 28 days |
| D012996 |
| Solutions |
| D004364 | Pharmaceutical Preparations |