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Completed Phase 2 Interventional Results available

Aerosolized Amikacin and Fosfomycin in Mechanically Ventilated Patients With Gram-negative Pneumonia

ClinicalTrials.gov ID: NCT01969799

Public ClinicalTrials.gov record NCT01969799. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 3, 2026, 9:33 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT01969799
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Cardeas Pharma
Industry
Enrollment
143 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 80 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 30, 2013
Primary completion
Feb 29, 2016
Completion
Mar 31, 2016
Last update posted
Jul 1, 2017

2013 – 2016

United States locations

U.S. sites
16
U.S. states
11
U.S. cities
16
Facility City State ZIP Site status
Not listed Los Angeles California 90033
Not listed Gainesville Florida 32610
Not listed Jacksonville Florida 32209
Not listed Chicago Illinois 60612
Not listed Hazard Kentucky 41701
Not listed Lexington Kentucky 21686
Not listed Boston Massachusetts 02119
Not listed Burlington Massachusetts 01805
Not listed Springfield Massachusetts 01199
Not listed Detroit Michigan 48202
Not listed St Louis Missouri 63110
Not listed Omaha Nebraska 60198
Not listed Oklahoma City Oklahoma 73104
Not listed Knoxville Tennessee 37920
Not listed El Paso Texas 79905
Not listed Houston Texas 77030

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 25 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01969799, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 1, 2017 · Synced Sep 3, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01969799 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →