An interventional study of aerosol antibiotics in Ventilator Associated Pneumonia and Multi-antibiotic Resistance, sponsored by Shanghai 10th People's Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-05-07.
Sponsored by Shanghai 10th People's Hospital · Not applicable, Interventional, and Supportive care
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.
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.
2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.
This study's planned enrollment of 60 is below the median of 106 across 1,247 interventional studies indexed under Pneumonia.
Browse Pneumonia studies →Shanghai 10th People's Hospital is the lead sponsor of 167 studies on the registry; 45 are open to participants now.
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・After 48 hours of mechanical ventilation diagnosed VAP.
Exclusion Criteria:
aerosol combined intravenous antibiotics group,amikacin 15mg/kg, qd
Drug: aerosol antibiotics
this group follow the usual treatment without any intervention
use of inhaled Antibacterial drug combined with intravenous antibiotics to treatment multiple drug resistance GNB ventilator associated pneumonia.
CPIS score changes
use clinical pulmonary infection score scale to evaluate score change from baseline for every patient
Time frame: 14 days
renal function changes
record changes in renal function assessed by SCr, blood urea nitrogen,etc.
Time frame: 14 days
ventilator free days in 14 days
record number of days with no ventilator support from day 1 through day 14
Time frame: 14 days
14-day mortality rate
rate of mortality from day 1 to day 14
Time frame: 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
Time frame: 14 days
This study is status unknown, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Shanghai 10th People's Hospital