Status:
COMPLETED
Inhaled Amikacin Solution BAY41-6551 as Adjunctive Therapy in the Treatment of Gram-Negative Pneumonia
Lead Sponsor:
Bayer
Collaborating Sponsors:
Nektar Therapeutics
Conditions:
Pneumonia, Bacterial
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
To demonstrate that as adjunctive therapy to intravenous (IV) antibiotics, BAY 41-6551 400 mg (amikacin as free base) administered as an aerosol by the Pulmonary Drug Delivery System (PDDS) Clinical e...
Eligibility Criteria
Inclusion
- 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
- Presence of Gram-negative organism(s) by either Gram stain or culture of respiratory secretions, or suspected Gram-negative pathogen
- Impaired oxygenation
- Clinical Pulmonary Infection Score (CPIS) of at least 6
- Presence of a multi-drug resistant (MDR) organism in a pre-therapy respiratory specimen OR at least two risk factors for MDR organisms
Exclusion
- History of hypersensitivity to amikacin or other aminoglycosides
- Has received antibiotic therapy for Gram-negative pneumonia for greater than 48 hours at the time of randomization
- Known or suspected bacteremia secondary to Staphylococcus aureus
- A positive urine and/or serum beta-human Chorionic Gonadotropin pregnancy test
- Patients with a serum creatinine \> 2 mg/dL (177 µmol/L) \[Exception: Patients with a serum creatinine \> 2 mg/dL (177 µmol/L) and being treated with continuous renal replacement therapy (Continuous Veno-Venous Hemodialysis and CVVHemoDiafiltration) or daily hemodialysis will receive the aerosol study drug treatment\]
- Has been on mechanical ventilation for \> 28 days
- Is participating in or has participated in other investigational interventional studies within the last 28 days prior to study treatment
- The risk of rapidly fatal illness and death within 72 hrs, or any concomitant condition not related to ventilator-associated pneumonia that, in the opinion of the investigator, precludes completion of study evaluations and the course of therapy
- Has an Acute Physiology and Chronic Health Evaluation (APACHE) II score \< 10
- Patients receiving veno-venous extracorporeal circulation membrane oxygenation (V-V ECMO)
Key Trial Info
Start Date :
April 13 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 7 2017
Estimated Enrollment :
725 Patients enrolled
Trial Details
Trial ID
NCT01799993
Start Date
April 13 2013
End Date
April 7 2017
Last Update
July 23 2018
Active Locations (65)
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1
Birmingham, Alabama, United States, 35233
2
Mobile, Alabama, United States, 36617
3
Phoenix, Arizona, United States, 85008-4956
4
Danbury, Connecticut, United States, 06810