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)

Phase 2

Completed

• Conditions: Pneumonia
• Interventions: Drug: Amikacin (BAY41-6551); Drug: Placebo

• Registration Number: NCT01004445
• Lead Sponsor: Bayer

Brief Summary

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2005-05
• Primary Completion: 2006-06
• Study Completion: 2006-06
• Study First Submitted: 2009-10-29
• Study First Submitted QC: 2009-10-29
• Study First Posted: 2009-10-30
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-07
• Last Update Posted: 2011-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

• 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

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Exclusion Criteria

• Patients with compromised of suppressed immune systems, severe hypoxemia, PEEP>15cm H2O, creatinine>2 mg/dL, or who are pregnant

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Amikacin (BAY41-6551)	-
Arm 2	Amikacin (BAY41-6551)	-
Arm 3	Placebo	-

Primary Outcome Measures

Name	Time	Method
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	Day 1

Secondary Outcome Measures

Name	Time	Method
Mean C(max) and mean AUC of amikacin in tracheal aspirates	Day 1 and Day 3 of treatment period
Mean ratio of C (max) / MIC and mean ratio of AUC (0-24 hr) / MIC	Day 1 and Day 3 of treatment period
Clinical cure rate	Test of cure visit (7 days post last treatment dose)
Microbiological eradication rate of identified pathogens	Test of cure visit (7 days post last treatment dose)
Microbiological persistence rate	Test of cure visit (7 days post last treatment dose)
New infection rate	Test of cure visit (7 days post last treatment dose)
Assessment of adverse events related to drug or device	Treatment period, early post treatment period, test of cure visit, and late post treatment
Assessment of abnormal laboratory values	Treatment period, early post treatment period, test of cure visit, and late post treatment