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)

Bayer

Status and phase: Completed; Phase 2

Conditions: Pneumonia

Treatments: Drug: Amikacin (BAY41-6551); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01004445

AMIK-04-02

Details and patient eligibility

About

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).

Enrollment: 69 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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69 participants in 3 patient groups, including a placebo group

Arm 1

Experimental group

Treatment:

Drug: Amikacin (BAY41-6551)

Drug: Amikacin (BAY41-6551)

Arm 2

Experimental group

Treatment:

Drug: Amikacin (BAY41-6551)

Drug: Amikacin (BAY41-6551)

Arm 3

Placebo Comparator group

Treatment:

Drug: Placebo