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

NCT01969799 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 143

Last updated 2017-07-02

Study results available
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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.

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 eFlow Inline System

DRUG

Aerosolized placebo

Placebo twice daily for 10 days to be administered by aerosol the eFlow Inline System

Sponsors & Collaborators

  • Cardeas Pharma

    lead INDUSTRY

Principal Investigators

  • Marin Kollef, M.D. · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2016-03-31
Completion
2016-04-30

Countries

  • United States
  • France
  • Greece
  • Hungary
  • Puerto Rico
  • Spain
  • Turkey (Türkiye)

Study Locations

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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 NCT01969799 on ClinicalTrials.gov