Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose

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


Condition Intervention Phase
Pneumonia
Drug: Amikacin Inhalation Solution (BAY41-6551)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Male serum C(max), T(max) and AUC( 0-12hour) [ Time Frame: Day 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 30
Study Start Date: March 2007
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01021436

Locations
United States, Alabama
VA Medical Center
Birminghan, Alabama, United States, 35233
United States, Ohio
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45267
United States, Tennessee
University of Tennessee Health Science Center
Memphis, Tennessee, United States, 38163
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
France
Hôpital de la Pitié - Salpétriè
Paris, Cedex 13, France, 75651
CHU Dupuytren
Limoges, Cedex, France, 87046
Sponsors and Collaborators
Bayer
Nektar Therapeutics
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided by Bayer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Head Clinical Pharmacology, Bayer HealthCare Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT01021436     History of Changes
Other Study ID Numbers: 06-IN-AK004
Study First Received: November 25, 2009
Last Updated: November 25, 2009
Health Authority: France: French Health Products Safety Agency
United States: Food and Drug Administration

Keywords provided by Bayer:
Pneumonia
Gram-negative bacteria

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Amikacin
Anti-Bacterial Agents
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014