Ignite Creation Date:
2024-05-06 @ 3:09 AM
Last Modification Date:
2024-10-26 @ 11:29 AM
Study NCT ID:
NCT02218359
Status:
WITHDRAWN
Last Update Posted:
2015-11-18
First Post:
2014-08-14
Brief Title:
Aerosolized Amikacin and Fosfomycin in Mechanically Ventilated Patients With Gram-negative and or Gram-positive Bacterial Colonization
Sponsor:
Cardeas Pharma
Organization:
Cardeas Pharma
Study Overview
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 Mechanically Ventilated Patients With Gram-negative andor Gram-positive Bacterial Colonization
Status:
WITHDRAWN
Status Verified Date:
2015-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No Participants Enrolled
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Description:
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 andor Gram-positive bacterial density at the end of the 5-day randomized course of study drug
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None