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

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.

Study Overview

• Status: Unknown
• Conditions: Ventilator Associated Pneumonia; Multi-antibiotic Resistance
• Intervention / Treatment: Drug: aerosol antibiotics

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: qixing wang, bs; Phone Number: 862166307153; Email: wangqixing1221@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200072
      • Recruiting
      • Shanghai Tenth People's Hospital
      • Contact: qixing wang; Phone Number: 862166307153; Email: wangqixing1221@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: aerosol combined group; aerosol combined intravenous antibiotics group，amikacin 15mg/kg, qd	Drug: aerosol antibiotics; use of inhaled Antibacterial drug combined with intravenous antibiotics to treatment multiple drug resistance GNB ventilator associated pneumonia.
No Intervention: No intervention group; this group follow the usual treatment without any intervention

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ventilator free days in 14 days	record number of days with no ventilator support from day 1 through day 14	14 days
14-day mortality rate	rate of mortality from day 1 to day 14	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	14 days

Collaborators and Investigators

• Sponsor: Shanghai 10th People's Hospital
• Investigators: Principal Investigator: hao liu, master, Shanghai 10th People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Anticipated): December 30, 2019
• Study Completion (Anticipated): January 1, 2020

Study Registration Dates

• First Submitted: November 20, 2017
• First Submitted That Met QC Criteria: April 17, 2019
• First Posted (Actual): April 19, 2019

Study Record Updates

• Last Update Posted (Actual): May 7, 2019
• Last Update Submitted That Met QC Criteria: May 6, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Pneumonia; Pneumonia, Ventilator-Associated; Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: ACAMP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No