Clinical Trial: Effect of Additional Nebulized Amikacin in Ventilator-Associated Pneumonia Caused by Gram Negative Bacteria

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Effect of Additional Nebulized Amikacin in Ventilator-Associated Pneumonia Caused by Gram Negative Bacteria

Brief Summary: The purpose of this study is to determine the cure rate from ventilator-associated pneumonia (VAP) caused by Gram negative bacteria when administering add on nebulized amikacin to intravenous antibiotics compared to intravenous antibiotics alone.

Detailed Summary: After inclusion, the patients are randomized into two groups: nebulized amikacin plus intravenous antibiotic(s) or nebulized placebo plus intravenous antibiotic(s). The dose of nebulized amikacin is 400 mg every 12 hours for 10 days. The patients are followed up on day 3, 7, 10, and 28 for safety and efficacy. The estimate sample size is 84 subjects base on previous study of cure rate in VAP and the authors expected that nebulized amikacin can improve cure rate in VAP subjects for 30% when compared with intravenous antibiotic(s) alone with power of 80% at level of significance 0.05.
Sponsor: Thammasat University

Current Primary Outcome: cure rate [ Time Frame: 10 days after end of the intervention ]

Cure rate = improvement/ no new infiltration of chest radiography plus 2/3 of the following: 1) No fever within 48 hours after end of the intervention 2) The reduction of secretion 3) The reduction of white blood cell


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The reduction of pathogens [ Time Frame: 10 days after end of the intervention ]
    quantitative sputum cultures were measured every days for 10 days or no growth of organism.
  • mortality rate [ Time Frame: at 28 days after end of the intervention ]
    All causes of death during the intervention
  • duration of mechanical ventilation [ Time Frame: at 28 days after end of the intervention ]
    number of days on mechanical ventilation
  • duration of ICU stay [ Time Frame: at 28 days after end of the intervention ]
    number of ICU days
  • duration of hospitalization [ Time Frame: at 28 days after end of the intervention ]
    number of days hospitalization
  • Safety of intervention drug [ Time Frame: at 28 days after end of the intervention ]
    Any adverse events were recorded


Original Secondary Outcome:

  • The reduction of pathogens [ Time Frame: 10 days after end of the inetrvention ]
    quantitative sputum cultures were measured every days for 10 days or no growth of organism.
  • mortality rate [ Time Frame: at 28 days after end of the intervention ]
    All causes of death during the intervention
  • duration of mechanical ventilation [ Time Frame: at 28 days after end of the intervention ]
    number of days on mechanical ventilation
  • duration of ICU stay [ Time Frame: at 28 days after end of the intervention ]
    number of ICU days
  • duration of hospitalization [ Time Frame: at 28 days after end of the intervention ]
    number of days hospitalization
  • Safety of intervention drug [ Time Frame: at 28 days after end of the intervention ]
    Any adverse events were recorded


Information By: Thammasat University

Dates:
Date Received: October 9, 2015
Date Started: July 2015
Date Completion: December 2017
Last Updated: October 11, 2016
Last Verified: October 2016