|
Clinical
Research Study
Mercy St. Vincent Medical Center
|
Inhaled Amikacin Solution (BAY41-6551) as Adjunctive Therapy
in the Treatment of Gram-Negative Pneumonia
Sponsored by: Bayer, December 2008
Purpose
To evaluate if inhaled Amikacin Solution will increase the ability
and safety of this antibiotic to treat Pneumonia in addition to giving intravenous
antibiotics in patients who are intubated and mechanically-ventilated.
Eligibility
| Ages Eligible for Study: |
18 Years and older |
| Genders Eligible for Study: |
Both |
| Accepts Healthy Volunteers: |
No |
Criteria
Inclusion Criteria:
- Males and non-pregnant, non-lactating females, 18 years of age or older
- Intubated and mechanically-ventilated
- Diagnosis of pneumonia defined as presence of a new or progressive infiltrate(s)
on chest radiograph and presence of Gram-negative organism(s) by either Gram
stain or culture of respiratory secretions
- CPIS of at least 6
- At least two risk factors for multi-drug resistant organisms
Exclusion Criteria:
- Has received antibiotic therapy for Gram-negative pneumonia for greater
than 24 hours at the time of randomization
- Primary lung cancer or another malignancy metastatic to the lungs or other
known endobronchial obstructions
- Known or suspected active tuberculosis, cystic fibrosis, human immunodeficiency
virus (HIV) infection with CD 4 count < 200 cell/mm3, or invasive fungal
infection of the lung
- Has had a stroke within five days
- Burns greater than 40% of total body surface area
- Screening serum creatinine > 2 mg/dL (177 µmol/L)
- Has been on mechanical ventilation for > 28 days
- Positive serum
 pregnancy
test
Contacts
Physicians:
Vijay Mahajan, MD
James Tita, DO
Srinivas Katragadda, MD
Coordinators:
Pamela Beavers, RN, CCRC
Dee Tilley, RN, CCRC
Tina Steinhauser, BSN, CCRC
Lisa S Graham, RN, CCRC
Please contact us at 419-251-4919 for more information about this study.
|
