Viewing Study NCT01969799



Ignite Creation Date: 2024-05-06 @ 2:05 AM
Last Modification Date: 2024-10-26 @ 11:14 AM
Study NCT ID: NCT01969799
Status: COMPLETED
Last Update Posted: 2017-07-02
First Post: 2013-10-22

Brief Title: Aerosolized Amikacin and Fosfomycin in Mechanically Ventilated Patients With Gram-negative Pneumonia
Sponsor: Cardeas Pharma
Organization: Cardeas Pharma

Study Overview

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
Status: COMPLETED
Status Verified Date: 2016-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: IASIS
Brief 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
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 and fosfomycin solution delivered by aerosol to the lungs via the PARI Investigational eFlow Inline System eFlow Inline System All patients will receive a standardized course of intravenous IV antibiotics for a minimum of 7 days Patients will be randomized to receive 10 days of treatment with either AFIS or placebo in addition to the IV therapy The primary efficacy endpoint is defined as the change from baseline in the Clinical Pulmonary Infection Score CPIS during the randomized course of study drug The study was designed to enroll up to 150 patients with the desire to enroll at least 140 patients with gram negative pneumonia The study was terminated at 143 when that goal was achieved

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
Secondary IDs
Secondary ID Type Domain Link
2013-002855-13 EUDRACT_NUMBER None None