Use of Aaerosol Combined With Intravenous Antibiotics for the Treatment of Multidrug Resistant GNB Pneumonia

Study Overview
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Brief Summary
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To investigate use of aerosol combined with intravenous antibiotics for the treat of multi-drug resistance gram negative bacterias diagnosed ventilator-associated pneumonia in intensive care unit in a hospital.

Detailed Description
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Ventilator-associated pneumonia (VAP) refers to the endotracheal tube or tracheostomy patients pneumonia after 48h of mechanical ventilation, mechanical ventilation is one of the most common and most serious complications, hospital acquired is An important cause of pneumonia. According to the onset time of VAP, VAP can be divided into early-onset VAP and late-onset VAP. The time limit is mechanical ventilation for 4 days, in which early-onset VAP (mechanical ventilation ≤ 4d) is mainly caused by pathogens sensitive to most antibacterial drugs (such as methicillin-sensitive Staphylococcus aureus, Streptococcus pneumoniae, etc.); late-onset VAP ≥ 5D occur during mechanical ventilation, mainly caused by multi-drug resistant (multi-drug resistance, MDR) (such as P. aeruginosa, Acinetobacter baumannii, methicillin-resistant Staphylococcus aureus). Some early-onset VAPs can also be caused by MDR. Therefore, MDR has become the main pathogen of VAP, especially Gram-negative bacilli. Studies have shown that VDR caused by MDR has a mortality rate of 76% and an attributable mortality rate of 20-30%. Such bacteria are not sensitive to commonly used antibacterial drugs in the clinic, and sensitive antibiotics, such as aminoglycosides, have a large systemic side effect, thereby limiting clinical use. Therefore, in theory, nebulized inhaled sensitive antibiotics can achieve high drug concentrations in lung tissue, and lower blood concentrations can avoid or reduce systemic side effects.

Official Title
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Use of Aaerosol Combined With Intravenous Antibiotics for the Treatment of Multidrug Resistant GNB Pneumonia

Conditions
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Ventilator Associated Pneumonia, Multi-antibiotic Resistance

Intervention / Treatment
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* Drug: aerosol antibiotics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ・After 48 hours of mechanical ventilation diagnosed VAP. Exclusion Criteria: Maternal who not meet the age limits, used amikacin within 15 days, allergic to amikacin, APACHE II score > 35, severe neutropenia unrelated to sepsis or meningitis, unable to retain specimens

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: aerosol combined group<br>aerosol combined intravenous antibiotics group，amikacin 15mg/kg, qd | Drug: aerosol antibiotics<br>* use of inhaled Antibacterial drug combined with intravenous antibiotics to treatment multiple drug resistance GNB ventilator associated pneumonia.<br>|
| No Intervention: No intervention group<br>this group follow the usual treatment without any intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CPIS score changes | use clinical pulmonary infection score scale to evaluate score change from baseline for every patient | 14 days | 
| renal function changes | record changes in renal function assessed by SCr, blood urea nitrogen,etc. | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ventilator free days in 14 days | record number of days with no ventilator support from day 1 through day 14 | 14 days | 
| 14-day mortality rate | rate of mortality from day 1 to day 14 | 14 days | 
| Drug resistance induction rate | Drug resistance induction rate is The number of cases of antibiotic-resistant species from the previous increase divided by the total number of patients included | 14 days |