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

Primary Purpose

Ventilator Associated Pneumonia, Multi-antibiotic Resistance

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
aerosol antibiotics
Sponsored by
Shanghai 10th People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Ventilator Associated Pneumonia

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shanghai tenth people's hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

aerosol combined group

No intervention group

Arm Description

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

this group follow the usual treatment without any intervention

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

ventilator free days in 14 days
record number of days with no ventilator support from day 1 through day 14
14-day mortality rate
rate of mortality from day 1 to day 14
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

Full Information

First Posted
November 20, 2017
Last Updated
May 6, 2019
Sponsor
Shanghai 10th People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03921645
Brief Title
Use of Aaerosol Combined With Intravenous Antibiotics for the Treatment of Multidrug Resistant GNB Pneumonia
Acronym
ACAMP
Official Title
Use of Aaerosol Combined With Intravenous Antibiotics for the Treatment of Multidrug Resistant GNB Pneumonia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
December 30, 2019 (Anticipated)
Study Completion Date
January 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai 10th People's Hospital

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilator Associated Pneumonia, Multi-antibiotic Resistance

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
aerosol combined group
Arm Type
Experimental
Arm Description
aerosol combined intravenous antibiotics group,amikacin 15mg/kg, qd
Arm Title
No intervention group
Arm Type
No Intervention
Arm Description
this group follow the usual treatment without any intervention
Intervention Type
Drug
Intervention Name(s)
aerosol antibiotics
Intervention Description
use of inhaled Antibacterial drug combined with intravenous antibiotics to treatment multiple drug resistance GNB ventilator associated pneumonia.
Primary Outcome Measure Information:
Title
CPIS score changes
Description
use clinical pulmonary infection score scale to evaluate score change from baseline for every patient
Time Frame
14 days
Title
renal function changes
Description
record changes in renal function assessed by SCr, blood urea nitrogen,etc.
Time Frame
14 days
Secondary Outcome Measure Information:
Title
ventilator free days in 14 days
Description
record number of days with no ventilator support from day 1 through day 14
Time Frame
14 days
Title
14-day mortality rate
Description
rate of mortality from day 1 to day 14
Time Frame
14 days
Title
Drug resistance induction rate
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
qixing wang, bs
Phone
862166307153
Email
wangqixing1221@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hao liu, master
Organizational Affiliation
Shanghai 10th People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai tenth people's hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200072
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
qixing wang
Phone
862166307153
Email
wangqixing1221@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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