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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


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


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Click here and search for drug information provided by the FDA

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Starting date: March 2007
Last updated: November 25, 2009

Page last updated: August 20, 2015

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