Overview
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)
Status:
Completed
Completed
Trial end date:
2006-06-01
2006-06-01
Target enrollment:
0
0
Participant gender:
All
All
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).Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
BayerCollaborator:
Nektar TherapeuticsTreatments:
Amikacin
Criteria
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