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Safety, Tolerability and Pharmacokinetics of Aerosolized Amikacin in Intubated and Mechanically-ventilated Patients With Nosocomial Pneumonia

This study has been completed.
Sponsor:
Collaborator:
Nektar Therapeutics
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01021436
First received: November 25, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted

November 25, 2009
November 25, 2009
March 2007
August 2007   (final data collection date for primary outcome measure)
Male serum C(max), T(max) and AUC( 0-12hour) [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Mean urine Xu(0-12 hour) [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
  • Mean urine Xu(12-24 hour) [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
  • Mean urine Xu(0-24 hour) [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
  • Assessment of adverse Events related to the study drug or study device [ Time Frame: Treatment period, test of cure visit, follow-up visit ] [ Designated as safety issue: Yes ]
  • Assessment of abnormal lab values [ Time Frame: Treatment period, test of cure visit, follow-up visit ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Safety, Tolerability and Pharmacokinetics of Aerosolized Amikacin in Intubated and Mechanically-ventilated Patients With Nosocomial Pneumonia
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

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
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Pneumonia
Drug: Amikacin Inhalation Solution (BAY41-6551)
Daily dose of 800mg of aerosolized amikacin delivered in two divided doses of 400mg per aerosol treatment 12 hour
Experimental: Arm 1
Intervention: Drug: Amikacin Inhalation Solution (BAY41-6551)
Luyt CE, Clavel M, Guntupalli K, Johannigman J, Kennedy JI, Wood C, Corkery K, Gribben D, Chastre J. Pharmacokinetics and lung delivery of PDDS-aerosolized amikacin (NKTR-061) in intubated and mechanically ventilated patients with nosocomial pneumonia. Crit Care. 2009;13(6):R200. Epub 2009 Dec 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
August 2007
August 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   France
 
NCT01021436
06-IN-AK004
No
Head Clinical Pharmacology, Bayer HealthCare Pharmaceuticals Inc.
Bayer
Nektar Therapeutics
Study Director: Bayer Study Director Bayer
Bayer
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP