Trial Condition(s):
Safety, tolerability and pharmacokinetics of aerosolized amikacin in intubated and mechanically-ventilated patients with nosocomial pneumonia
06-IN-AK004
Not Available
This study is to understand how the inhaled form of amikacin is spread throughout the human body and how it is eliminated from the body and to make sure that giving an inhaled form of Amikacin to patients is safe and well tolerated
- Male or female subjects with confirmed pneumonia, defined as the presence of a new progressive infiltrate(s) on chest radiograph and the presence of gram-negative organism by either culture or Gram stain of respiratory secretions. The subject must be intubated and mechanically ventilated and expected to remain so for at least 3 days after the start of study treatment. Subjects with a tracheostomy were also eligible.
- Subjects with compromised or suppressed Immune systems, severe hypoxemia, neutropenia, serum creatinine > 2mg/dl and chronic liver disease - Had primary lung cancer or another malignancy metastatic to the lungs - Were known or suspected to have active tuberculosis, cystic fibrosis, acquired immunodeficiency syndrome, or Pneumocystis carinii pneumonia - Were receiving immunosuppressive therapy, defined as chronic treatment with known immunosuppressant medications - Had a body mass index of ≥30 kg/m2 - Had burns >40% of total body surface area - Had known local or systemic hypersensitivity to amikacin or aminoglycosides - Had a diagnosis of end-stage renal failure or were currently on dialysis treatment - Had a serum albumin level <2 g/dL at Screening - Used amikacin by any route within 7 days before the start of study treatment - Had a presence of any concomitant condition that, in the opinion of the investigator, would preclude completion of study evaluations or make it unlikely that the contemplated course of therapy and Follow-Up could be completed - Had known respiratory colonization with amikacin-resistant gram-negative rods
Locations | |
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Locations Hôpital de la Pitié - Salpétriè Paris, France, 75651 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CHU Dupuytren Limoges, France, 87046 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Baylor College of Medicine Houston, United States, 77030 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Cincinnati Medical Center Cincinnati, United States, 45267 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations VA Medical Center Birminghan, United States, 35233 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Tennessee Health Science Center Memphis, United States, 38163 | Contact Us: E-mail: [email protected] Phone: Not Available |
An Open-Label, Multicenter, Multinational Study to assess the Safety,Tolerability and Pharmacokinetics of Aerosolized Amikacin delivered via the Pulmonary Drug Delivery System (NKTR-061) in Intubated and Mechanically- ventilated Patients with Nosocomial Pneumonia
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
N/A
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1