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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01021436 |
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Date of registration:
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25/11/2009 |
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Primary sponsor: |
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Public title:
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Safety, Tolerability and Pharmacokinetics of Aerosolized Amikacin in Intubated and Mechanically-ventilated Patients With Nosocomial Pneumonia
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Scientific title:
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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 |
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Date of first enrolment:
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March 2007 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01021436 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
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Countries of recruitment
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France
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United States
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Contacts
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Name:
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Bayer Study Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Bayer |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Pneumonia
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Intervention(s)
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Drug: Amikacin Inhalation Solution (BAY41-6551)
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Primary Outcome(s)
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Male serum C(max), T(max) and AUC( 0-12hour)
[Time Frame: Day 3]
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Secondary Outcome(s)
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Assessment of abnormal lab values
[Time Frame: Treatment period, test of cure visit, follow-up visit]
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Assessment of adverse Events related to the study drug or study device
[Time Frame: Treatment period, test of cure visit, follow-up visit]
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Mean urine Xu(0-12 hour)
[Time Frame: Day 3]
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Mean urine Xu(0-24 hour)
[Time Frame: Day 3]
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Mean urine Xu(12-24 hour)
[Time Frame: Day 3]
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Secondary ID(s)
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06-IN-AK004
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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