Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
With
Nektar Therapeutics
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
