Clinical Trial: Aerosolized Amikacin and Fosfomycin in Mechanically Ventilated Patients With Gram-negative and / or Gram-positive Bacterial Colonization

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: A Randomized Double-Blind, Placebo-Controlled, Crossover to Open Label, Phase 2 Study of Aerosolized Amikacin and Fosfomycin Delivered Via the Investigational eFlow® AFIS Inline System in Mechani

Brief Summary: To demonstrate the safety and efficacy of adjunctive therapy with the Amikacin Fosfomycin Inhalation System (AFIS) versus aerosolized placebo in mechanically ventilated patients with Gram-negative and / or Gram-positive bacterial colonization.

Detailed Summary: The primary purpose of this study is to demonstrate the safety and efficacy of the amikacin fosfomycin inhalation system (AFIS). AFIS consists of amikacin solution (AMS) and fosfomycin solution (FFS), delivered by aerosol to the lungs via the Investigational eFlow AFIS Inline System (AFIS Inline System) with tamper evident reservoir. Patients will be randomized to receive 5 days of treatment with either AFIS or placebo, followed by all patients receiving open label AFIS for five days. The primary efficacy endpoint is the change from baseline in tracheal aspirate Gram-negative and/or Gram-positive bacterial density at the end of the 5-day randomized course of study drug.
Sponsor: Cardeas Pharma

Current Primary Outcome: Change from baseline in tracheal aspirate Gram-negative and Gram-positive bacterial density [ Time Frame: 5 day randomized course of study drug ]

Change from baseline in tracheal aspirate Gram-negative and Gram-positive bacterial density at the end of the 5-day randomized course of study drug


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Microbiological response rate in patients with multidrug resistant Gram-negative bacteria [ Time Frame: Day 5 ]
    Microbiological response rates at Day 5 in patients whose pre-study treatment tracheal aspirate culture was positive for multidrug resistant (MDR) Gram-negative bacteria
  • Eradication of bacteria [ Time Frame: Days 10, 21, and 28 ]
    Eradication of bacteria at Days 10, 21, and 28
  • Clinical worsening [ Time Frame: Day 1 - Day 28 ]
    Clinical worsening (defined as requiring institution of IV antibiotics) from Day 1 through Day 28
  • Microbiological response rates [ Time Frame: Day 10 ]
    Microbiological response rates at Day 10 in all patients
  • Microbiological response rates in patients with MRSA [ Time Frame: Day 5 ]
    Microbiological response rates at Day 5 in patients whose pre-study treatment tracheal aspirate culture was positive for methicillin resistant Staphylococcus aureus (MRSA)


Original Secondary Outcome: Same as current

Information By: Cardeas Pharma

Dates:
Date Received: August 14, 2014
Date Started: October 2014
Date Completion: January 2016
Last Updated: November 16, 2015
Last Verified: November 2015