At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 143 enrolled
Drug / intervention
Amikacin fosfomycin inhalation solution +1 moredrug
Likely dose
Amikacin fosfomycin inhalation solution 300 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Blinded, Placebo-Controlled, Phase 2 Study of Aerosolized Amikacin and Fosfomycin Delivered Via the Investigational eFlow® Inline System in Mechanically Ventilated Patients With Gram-negative Bacterial Pneumonia (IASIS)
In Brief
A Phase 2 clinical trial evaluating Amikacin fosfomycin inhalation solution and Aerosolized placebo for Pneumonia, Bacterial. Completed, enrolled 143 participants across 41 sites in 7 countries.
Detailed Summary
To demonstrate the safety and efficacy of adjunctive therapy with the Amikacin fosfomycin inhalation system (AFIS) versus aerosolized placebo to treat Gram-negative pneumonia in mechanically ventilated patients receiving IV antibiotics.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPneumonia, Bacterial
CountriesFrance, Greece, Hungary, Puerto Rico, Spain, Turkey (Türkiye), United States
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 2013
Enrollment StartDec 2013
Primary CompletionMar 2016
Study CompletionApr 2016
TodayJul 2026
First PostedOct 25, 2013
Enrollment StartDec 1, 2013
Primary CompletionMar 1, 2016
Study CompletionApr 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 12.7 years ago
Interventions
Amikacin fosfomycin inhalation solutiondrug
300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System
Aerosolized placebodrug
Placebo twice daily for 10 days to be administered by aerosol the eFlow Inline System