Use of Aaerosol Combined With Intravenous Antibiotics for the Treatment of Multidrug Resistant GNB Pneumonia
Overview
- Phase
- Not Applicable
- Intervention
- aerosol antibiotics
- Conditions
- Ventilator Associated Pneumonia
- Sponsor
- Shanghai 10th People's Hospital
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- CPIS score changes
- Last Updated
- 6 years ago
Overview
Brief Summary
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
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.
Investigators
Sheng Wang MD PhD
Director, Principal investigator
Shanghai 10th People's Hospital
Eligibility Criteria
Inclusion Criteria
- •・After 48 hours of mechanical ventilation diagnosed VAP.
Exclusion Criteria
- •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
Arms & Interventions
aerosol combined group
aerosol combined intravenous antibiotics group，amikacin 15mg/kg, qd
Intervention: aerosol antibiotics
Outcomes
Primary Outcomes
CPIS score changes
Time Frame: 14 days
use clinical pulmonary infection score scale to evaluate score change from baseline for every patient
renal function changes
Time Frame: 14 days
record changes in renal function assessed by SCr, blood urea nitrogen,etc.
Secondary Outcomes
- Drug resistance induction rate(14 days)
- ventilator free days in 14 days(14 days)
- 14-day mortality rate(14 days)