Clinical Trial: A Study to Assess the Pharmacokinetic Profile, the Safety, and the Tolerability of ME1100 Inhalation Solution in Patients With Mechanically Ventilated Bacterial Pneumonia

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

Official Title: A Randomized, Open-Label Phase 1b Study of ME1100 Inhalation Solution Plus Best Available Therapy in the Treatment of Mechanically Ventilated Subjects With Bacterial Pneumonia

Brief Summary: This study is a randomized, open-label phase I study. The primary objective of this study is to assess the pharmacokinetic (PK) profile of ME1100 in subjects with mechanically ventilated bacterial pneumonia (MVBP). The secondary objective of this study is to assess the safety and tolerability of ME1100 for the treatment of subjects with MVBP to assess the safety and tolerability of ME1100.

Detailed Summary:
Sponsor: Meiji Seika Pharma Co., Ltd.

Current Primary Outcome:

  • Arbekacin concentrations in respiratory fluids collected via bronchoalveolar lavage (BAL) for epithelial lining fluid (ELF) [ Time Frame: Day 3 ]
  • Plasma arbekacin concentrations [ Time Frame: Day 1 to Day 5 ]
  • Urinary elimination of arbekacin [ Time Frame: Day 2 ]
  • Arbekacin concentrations in tracheal aspirate [ Time Frame: Day 2 ]


Original Primary Outcome:

  • Arbekacin concentrations in respiratory fluids collected via bronchoalveolar lavage (BAL) for epithelial lining fluid (ELF) [ Time Frame: Day 3 ]
  • Plasma arbekacin concentrations [ Time Frame: Day 1 to Day 7 ]
  • Urinary elimination of arbekacin [ Time Frame: Day 2 ]
  • Arbekacin concentrations in tracheal aspirate [ Time Frame: Day 2 ]
  • Number of participants with adverse events [ Time Frame: Screening through 14 days after the end of treatment ]


Current Secondary Outcome: Number of participants with adverse events [ Time Frame: Screening through 14 days after the end of treatment ]

Original Secondary Outcome:

  • Proportion of cured participants at the test-of-cure visit [ Time Frame: 7 days after the end-of-treatment visit ]
  • Mortality [ Time Frame: Day 28 ]
  • Proporprtion of participants who achive microbiological eradication at the test-of-cure visit [ Time Frame: 7 days after the end-of-treatment visit ]


Information By: Meiji Seika Pharma Co., Ltd.

Dates:
Date Received: May 28, 2015
Date Started: September 2015
Date Completion:
Last Updated: November 1, 2016
Last Verified: November 2016