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Aerosolized Amikacin and Fosfomycin in Mechanically Ventilated Patients With Gram-negative and / or Gram-positive Bacterial Colonization

NCT02218359 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2015-11-18

No results posted yet for this study

Summary

To demonstrate the safety and efficacy of adjunctive therapy with the Amikacin Fosfomycin Inhalation System (AFIS) versus aerosolized placebo in mechanically ventilated patients with Gram-negative and / or Gram-positive bacterial colonization.

Conditions

  • Pneumonia, Bacterial

Interventions

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 AFIS Inline System

DRUG

Aerosolized placebo

Placebo twice daily for Days 1 -5 to be administered by aerosol using the eFlow Inline System.

DRUG

Amikacin Fosfomycin Inhalation Solution

Open-label crossover for all patients Days 6-10

Sponsors & Collaborators

  • Cardeas Pharma

    lead INDUSTRY

Principal Investigators

  • Bruce Montgomery, M.D. · Cardeas Pharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2015-12-31
Completion
2016-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02218359 on ClinicalTrials.gov