Aerosolized Amikacin and Fosfomycin in Mechanically Ventilated Patients With Gram-negative Pneumonia (IASIS)
|ClinicalTrials.gov Identifier: NCT01969799|
Recruitment Status : Completed
First Posted : October 25, 2013
Results First Posted : July 2, 2017
Last Update Posted : July 2, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pneumonia, Bacterial||Drug: Amikacin fosfomycin inhalation solution Drug: Aerosolized placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||143 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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)|
|Study Start Date :||December 2013|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||April 2016|
Experimental: Amikacin fosfomycin inhalation solution
300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System.
Drug: Amikacin fosfomycin inhalation solution
300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System
Placebo Comparator: Aerosolized placebo
Aerosolized placebo twice daily for 10 days administered using the eFlow Inline System
Drug: Aerosolized placebo
Placebo twice daily for 10 days to be administered by aerosol the eFlow Inline System
Other Name: eFlow Inline System
- Change From Baseline in Clinical Pulmonary Infection Score (CPIS) For Each Patient, Value Obtained From a Daily Assessment Over the 10 Day Study Period Was Compared to Baseline, and the LSM Data Represent the Change From Baseline Data Over All Days . [ Time Frame: 10 day treatment period. ]Change from baseline in Clinical Pulmonary Infection Score (CPIS) For each patient, value obtained from a daily assessment over the 10 day study period was compared to baseline, and the LSM data represent the change from baseline data over all days. Daily CPIS will be determined by one blinded, central reviewer in order to minimize inter-observer variability. The scale ranges from 0 to 13, with 13 being the worst. The value of zero would be a healthy patient with no evidence of pneumonia. For each patient, there was a daily assessment for the 10 day study period.
- Composite Endpoint of Mortality and Clinical Cure [ Time Frame: Day 1 - Day 28 ]The hierarchical composite endpoint of mortality, then clinical cure (defined as both absence of Gram-negative bacteria and CPIS at Day 14 < 6). The tables reflect a winner of matched pairs, ties are not noted.
- Composite Endpoint of Mortality and Ventilator-free Days [ Time Frame: Day 1- Day 28 ]The hierarchical composite endpoint of mortality, then ventilator-free days. The table reflects winners of matched pairs, ties are not noted.
- Number of Days Free of Mechanical Ventilation From Day 1 Through Day 28 [ Time Frame: Day 1 - Day 28 ]Number of days free of mechanical ventilation from Day 1 through Day 28 mean days.
- Number of ICU Days From Day 1 Through Day 28 [ Time Frame: Day 1 - Day 28 ]
- Microbiological Response Rates in Patients Positive for Multi-drug Resistant Gram-negative Bacteria [ Time Frame: Day 14 ]Microbiological response rates at Day 14 in patients whose pre-study treatment bronchoalveolar lavage (BAL) was positive for multi-drug resistant Gram-negative bacteria. Response is defined as not have a positive tracheal aspirate culture on Day 14
- Mortality From Day 1 Through Day 28 [ Time Frame: Day 1 - Day 28 ]Mortality from Day 1 through Day 28, all causes, does not reflect just infection only
- Clinical Relapse Rate [ Time Frame: Day 11 - Day 28 ]Clinical relapse rates (defined as a new episode of pneumonia requiring reinstitution of IV antibiotics) from Day 11 through Day 28
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01969799
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|Principal Investigator:||Marin Kollef, M.D.||Washington University School of Medicine|