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

Not Applicable

• Conditions: Ventilator Associated Pneumonia; Multi-antibiotic Resistance
• Interventions: Drug: aerosol antibiotics

• Registration Number: NCT03921645
• Lead Sponsor: Shanghai 10th People's Hospital

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.

Study Timeline

• Study First Submitted: 2017-11-20
• Study Start: 2018-01-01
• Status Verified: 2019-04
• Study First Submitted QC: 2019-04-17
• Study First Posted: 2019-04-19
• Last Update Submitted: 2019-05-06
• Last Update Posted: 2019-05-07
• Primary Completion: 2019-12-30
• Study Completion: 2020-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
aerosol combined group	aerosol antibiotics	aerosol combined intravenous antibiotics group，amikacin 15mg/kg, qd

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
ventilator free days in 14 days	14 days	record number of days with no ventilator support from day 1 through day 14
14-day mortality rate	14 days	rate of mortality from day 1 to day 14
Drug resistance induction rate	14 days	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

Trial Locations

Locations (1)

Shanghai tenth people's hospital; 🇨🇳 Shanghai, Shanghai, China