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出境医 / 临床实验 / Use of Aaerosol Combined With Intravenous Antibiotics for the Treatment of Multidrug Resistant GNB Pneumonia (ACAMP)

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

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.

Condition or disease Intervention/treatment Phase
Ventilator Associated Pneumonia Multi-antibiotic Resistance Drug: aerosol antibiotics Not Applicable

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 Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Use of Aaerosol Combined With Intravenous Antibiotics for the Treatment of Multidrug Resistant GNB Pneumonia
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : January 1, 2020
Arms and Interventions
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
Outcome Measures
Primary Outcome Measures :
  1. CPIS score changes [ Time Frame: 14 days ]
    use clinical pulmonary infection score scale to evaluate score change from baseline for every patient

  2. renal function changes [ Time Frame: 14 days ]
    record changes in renal function assessed by SCr, blood urea nitrogen,etc.


Secondary Outcome Measures :
  1. ventilator free days in 14 days [ Time Frame: 14 days ]
    record number of days with no ventilator support from day 1 through day 14

  2. 14-day mortality rate [ Time Frame: 14 days ]
    rate of mortality from day 1 to day 14

  3. Drug resistance induction rate [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Contacts
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Contact: qixing wang, bs 862166307153 wangqixing1221@163.com

Locations
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China, Shanghai
Shanghai tenth people's hospital Recruiting
Shanghai, Shanghai, China, 200072
Contact: qixing wang    862166307153    wangqixing1221@163.com   
Sponsors and Collaborators
Shanghai 10th People's Hospital
Investigators
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Principal Investigator: hao liu, master Shanghai 10th People's Hospital
Tracking Information
First Submitted Date  ICMJE November 20, 2017
First Posted Date  ICMJE April 19, 2019
Last Update Posted Date May 7, 2019
Actual Study Start Date  ICMJE January 1, 2018
Estimated Primary Completion Date December 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2019)
  • CPIS score changes [ Time Frame: 14 days ]
    use clinical pulmonary infection score scale to evaluate score change from baseline for every patient
  • renal function changes [ Time Frame: 14 days ]
    record changes in renal function assessed by SCr, blood urea nitrogen,etc.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2019)
  • ventilator free days in 14 days [ Time Frame: 14 days ]
    record number of days with no ventilator support from day 1 through day 14
  • 14-day mortality rate [ Time Frame: 14 days ]
    rate of mortality from day 1 to day 14
  • Drug resistance induction rate [ Time Frame: 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Use of Aaerosol Combined With Intravenous Antibiotics for the Treatment of Multidrug Resistant GNB Pneumonia
Official Title  ICMJE Use of Aaerosol Combined With Intravenous Antibiotics for the Treatment of Multidrug Resistant GNB Pneumonia
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Ventilator Associated Pneumonia
  • Multi-antibiotic Resistance
Intervention  ICMJE Drug: aerosol antibiotics
use of inhaled Antibacterial drug combined with intravenous antibiotics to treatment multiple drug resistance GNB ventilator associated pneumonia.
Study Arms  ICMJE
  • Experimental: aerosol combined group
    aerosol combined intravenous antibiotics group，amikacin 15mg/kg, qd
    Intervention: Drug: aerosol antibiotics
  • No Intervention: No intervention group
    this group follow the usual treatment without any intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 17, 2019) 		60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2020
Estimated Primary Completion Date December 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03921645
Other Study ID Numbers  ICMJE ACAMP
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sheng Wang MD PhD, Shanghai 10th People's Hospital
Study Sponsor  ICMJE Shanghai 10th People's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: hao liu, master Shanghai 10th People's Hospital
PRS Account Shanghai 10th People's Hospital
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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