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

Ventilator Associated Pneumonia Clinical Trial

— ACAMP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03921645
• Other study ID #: ACAMP
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: January 1, 2020

Study information

• Verified date: April 2019
• Source: Shanghai 10th People's Hospital
• Contact: qixing wang, bs
• Phone: 862166307153
• Email: wangqixing1221[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 1, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Multi-antibiotic Resistance
• Pneumonia
• Pneumonia, Ventilator-Associated
• Ventilator Associated Pneumonia

Intervention

Drug:
• aerosol antibiotics
use of inhaled Antibacterial drug combined with intravenous antibiotics to treatment multiple drug resistance GNB ventilator associated pneumonia.

Locations

Country	Name	City	State
China	Shanghai tenth people's hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 10th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CPIS score changes	use clinical pulmonary infection score scale to evaluate score change from baseline for every patient	14 days
Primary	renal function changes	record changes in renal function assessed by SCr, blood urea nitrogen,etc.	14 days
Secondary	ventilator free days in 14 days	record number of days with no ventilator support from day 1 through day 14	14 days
Secondary	14-day mortality rate	rate of mortality from day 1 to day 14	14 days
Secondary	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