check_circleStudy Completed

Pneumonia

Bayer Identifier:

AMIK-04-02

ClinicalTrials.gov Identifier:

NCT01004445

EudraCT Number:

2005-000060-16

EU CT Number:

Not Available
A study to determine the correct dose of amikacin which is delivered directly to the lungs of ventilated patients as an aerosol via an investigational device called the Pulmonary Delivery Device System (PDDS)

Trial purpose

This study is part of a research program too see if amikacin delivered as an aerosol directly to the lungs in combination with IV antibiotic therapy can help intubated patients with gram-negative pneumonia get better faster than when given intravenous antibiotics alone. The primary purpose of this study is to determine the correct dose of amikacin which is delivered directly to the lungs as an aerosol via an investigational device called the Pulmonary Delivery Device System (PDDS).

Key Participants Requirements

Sex

Both

Age

18 Years
  • - Male and female patients 18 years of age or older with a clinical diagnosis of VAP, HAP or HCAP who are expected to be on mechanical ventilation for at least 3 days
  • - Patients with compromised of suppressed immune systems, severe hypoxemia, PEEP>15cm H2O, creatinine>2 mg/dL, or who are pregnant

Trial summary

Enrollment Goal
69
Trial Dates
May 2005 - June 2006
Phase
Phase 2
Could I Receive a placebo
Yes
Products
Amikacin Inhalation Solution (BAY41-6551)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
San Antonio, 78229, United States
Completed
Houston, 77030, United States
Completed
Winston-Salem, 27157, United States
Completed
Birmingham, 35233, United States
Completed
Columbus, 43210, United States
Completed
Melbourne, 32901, United States
Completed
Albany, 12208, United States
Completed
Paris Cedex 14, 75674, France
Completed
Paris Cedex 13, 75651, France
Completed
Limoges Cedex, 87046, France
Completed
Paris Cedex 15, 75908, France
Completed
Angers Cedex 9, 49933, France
Completed
Rouen cedex, 76031, France
Completed
Paris, 75018, France
Completed
Madrid, 28805, Spain
Completed
Barcelona, 08036, Spain
Completed
Barcelona, 08003, Spain
Completed
Murcia, 30120, Spain
Completed
Madrid, 28034, Spain
Completed
Madrid, 28040, Spain

Primary Outcome

  • Proportion of patients who achieve a C(max) for amikacin in tracheal aspirates at least 25 times greater than the reference MIC for hospital-acquired organisms and an AUC (0-24 hr) / MIC ratio that is 100 or greater on Day 1
    date_rangeTime Frame:
    Day 1
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Mean C(max) and mean AUC of amikacin in tracheal aspirates
    date_rangeTime Frame:
    Day 1 and Day 3 of treatment period
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    Safety Issue:
    no
  • Mean ratio of C (max) / MIC and mean ratio of AUC (0-24 hr) / MIC
    date_rangeTime Frame:
    Day 1 and Day 3 of treatment period
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    Safety Issue:
    no
  • Clinical cure rate
    date_rangeTime Frame:
    Test of cure visit (7 days post last treatment dose)
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    Safety Issue:
    no
  • Microbiological eradication rate of identified pathogens
    date_rangeTime Frame:
    Test of cure visit (7 days post last treatment dose)
    enhanced_encryption
    Safety Issue:
    no
  • Microbiological persistence rate
    date_rangeTime Frame:
    Test of cure visit (7 days post last treatment dose)
    enhanced_encryption
    Safety Issue:
    no
  • New infection rate
    date_rangeTime Frame:
    Test of cure visit (7 days post last treatment dose)
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    Safety Issue:
    no
  • Assessment of adverse events related to drug or device
    date_rangeTime Frame:
    Treatment period, early post treatment period, test of cure visit, and late post treatment
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    Safety Issue:
    yes
  • Assessment of abnormal laboratory values
    date_rangeTime Frame:
    Treatment period, early post treatment period, test of cure visit, and late post treatment
    enhanced_encryption
    Safety Issue:
    yes

Trial design

A Double-Blind, Placebo-controlled Parallel Group, Phase II Dose-Ranging Study of Nebulized Amikacin Delivered via the Pulmonary Drug Delivery System (PDDS) in Ventilated Patients with Nosocomial Pneumonia Due to Gram Negative Organisms
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
3

Additional Information

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