Safety, Tolerability and Pharmacokinetics of Aerosolized Amikacin in Intubated and Mechanically-ventilated Patients With Nosocomial Pneumonia
Information source: Bayer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pneumonia
Intervention: Amikacin Inhalation Solution (BAY41-6551) (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Bayer Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer
Summary
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
Clinical Details
Official title: 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
Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: Male serum C(max), T(max) and AUC( 0-12hour)
Secondary outcome: Mean urine Xu(0-12 hour)Mean urine Xu(12-24 hour) Mean urine Xu(0-24 hour) Assessment of adverse Events related to the study drug or study device Assessment of abnormal lab values
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Male or female patients with confirmed pneumonia, defined as the presence of anew
progressive infiltrate(s) on chest radiograph and the presence of gram-negative
organism by either culture or Gram stain of respiratory secretions. The patient must
be intubated and mechanically ventilated and expected to remain so for at least 3
days after the start of study treatment
Exclusion Criteria:
- Patients with compromised or suppressed Immune systems, severe hypoxemia,
neutropenia, serum creatinine > 2mg/dl and chronic liver disease
Locations and Contacts
VA Medical Center, Birminghan, Alabama 35233, United States
CHU Dupuytren, Limoges, Cedex 87046, France
Hôpital de la Pitié - Salpétriè, Paris, Cedex 13 75651, France
University of Cincinnati Medical Center, Cincinnati, Ohio 45267, United States
University of Tennessee Health Science Center, Memphis, Tennessee 38163, United States
Baylor College of Medicine, Houston, Texas 77030, United States
Additional Information
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Starting date: March 2007
Last updated: November 25, 2009
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