Clinical trial NCT03921645: Use of Aaerosol Combined With Intravenous Antibiotics for the Treatment of Multidrug Resistant GNB Pneumonia
Official title: Use of Aaerosol Combined With Intravenous Antibiotics for the Treatment of Multidrug Resistant GNB Pneumonia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ventilator Associated Pneumonia
Multi-antibiotic Resistance
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2019-04-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: CPIS score changes
timeFrame: 14 days
measure: renal function changes
timeFrame: 14 days
Secondary outcomes:
measure: ventilator free days in 14 days
timeFrame: 14 days
measure: 14-day mortality rate
timeFrame: 14 days
measure: Drug resistance induction rate
timeFrame: 14 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai tenth people's hospital
state: Shanghai
Study officials:
affiliation: Shanghai 10th People's Hospital
name: hao liu, master
role: PRINCIPAL_INVESTIGATOR
References: