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Trial record 1 of 1 for:    NCT01021436
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Safety, Tolerability and Pharmacokinetics of Aerosolized Amikacin in Intubated and Mechanically-ventilated Patients With Nosocomial Pneumonia

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ClinicalTrials.gov Identifier: NCT01021436
Recruitment Status : Completed
First Posted : November 30, 2009
Last Update Posted : February 18, 2016
Sponsor:
Collaborator:
Nektar Therapeutics
Information provided by (Responsible Party):
Bayer

Study Description
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Brief 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

Condition or disease Intervention/treatment Phase
Pneumonia Drug: Amikacin inhalation solution (BAY41-6551) Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : March 2007
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arms and Interventions
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Arm Intervention/treatment
Experimental: Amikacin inhalation solution
Subjects received 125 mg/mL of aerosolized amikacin via the PDDS clinical device at a nominal dose of 400 mg every 12 h for 7-14 days
 Drug: Amikacin inhalation solution (BAY41-6551)
Daily dose of 800 mg of aerosolized amikacin delivered in two divided doses of 400 mg per aerosol treatment 12 hour


Outcome Measures
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Primary Outcome Measures :
  1. Cmax [ Time Frame: Pre-dose and up to 12 h post-dose after the start of dosing and also at 1 h and 12 h after the administration of the second dose ]
    Maximum serum amikacin concentration observed from time 0 to 12 h

  2. Tmax [ Time Frame: Pre-dose and up to 12 h post-dose after the start of dosing and also at 1 h and 12 h after the administration of the second dose ]
    Time that Cmax occurred

  3. AUC0-12h [ Time Frame: Pre-dose and up to 12 h post-dose after the start of dosing and also at 1 h and 12 h after the administration of the second dose ]
    Area under the serum amikacin concentration vs time curve from time 0 to 12 h

  4. Xu0-12h [ Time Frame: On Day 3 at the start of dose and up to 12 h after both first and second dose ]
    Amount of amikacin excreted in urine from 0 to 12 h after dosing

  5. Xu12-24h [ Time Frame: On Day 3 at the start of dose and up to 12 h after both first and second dose ]
    Amount of amikacin excreted in urine from 12 to 24 h after dosing

  6. Xu0-24h [ Time Frame: On Day 3 at the start of dose and up to 12 h after both first and second dose ]
    Amount of amikacin excreted in urine from 0 to 24 h after dosing

  7. Tracheal aspirate [ Time Frame: Day 3 ]
  8. Epithelial lining fluid (ELF) concentration [ Time Frame: Approximately 15-30 min after completion of the morning dose of study medication on Day 3 ]

Secondary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: Approximately 6 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01021436


Locations
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United States, Alabama
Birminghan, Alabama, United States, 35233
United States, Ohio
Cincinnati, Ohio, United States, 45267
United States, Tennessee
Memphis, Tennessee, United States, 38163
United States, Texas
Houston, Texas, United States, 77030
France
Paris, Cedex 13, France, 75651
Limoges, Cedex, France, 87046
Sponsors and Collaborators
Bayer
Nektar Therapeutics
Investigators
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Study Director: Bayer Study Director Bayer
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01021436    
Other Study ID Numbers: 06-IN-AK004
2006-005079-17 ( EudraCT Number )
First Posted: November 30, 2009    Key Record Dates
Last Update Posted: February 18, 2016
Last Verified: February 2016
Keywords provided by Bayer:
Pneumonia
Gram-negative bacteria
Additional relevant MeSH terms:
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Pneumonia
Healthcare-Associated Pneumonia
Respiratory Tract Infections
Infections
Lung Diseases
Respiratory Tract Diseases
Cross Infection
 Iatrogenic Disease
Disease Attributes
Pathologic Processes
Amikacin
Anti-Bacterial Agents
Anti-Infective Agents