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.

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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

Conditions

Pneumonia, Bacterial

Interventions

Amikacin fosfomycin inhalation solution Drug
Aerosolized placebo Drug

Drug

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: Dec 2013 (Type not available)
Primary completion: Mar 2016 (Actual)
Completion: Apr 2016 (Actual)
Last update posted: Jul 2, 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 2, 2017 · Synced Oct 19, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01969799 live on ClinicalTrials.gov.

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