check_circleStudy Completed
Pneumonia
Bayer Identifier:
06-IN-AK004
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Safety, tolerability and pharmacokinetics of aerosolized amikacin in intubated and mechanically-ventilated patients with nosocomial pneumonia
Trial 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
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
30Trial Dates
March 2007 - August 2007Phase
Phase 2Could I Receive a placebo
NoProducts
Amikacin Inhalation Solution (BAY41-6551)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Hôpital de la Pitié - Salpétriè | Paris, 75651, France |
Completed | CHU Dupuytren | Limoges, 87046, France |
Completed | Baylor College of Medicine | Houston, 77030, US |
Completed | University of Cincinnati Medical Center | Cincinnati, 45267, US |
Completed | VA Medical Center | Birminghan, 35233, US |
Completed | University of Tennessee Health Science Center | Memphis, 38163, US |
Primary Outcome
- CmaxMaximum serum amikacin concentration observed from time 0 to 12 hdate_rangeTime 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 doseenhanced_encryptionNoSafety Issue:
- TmaxTime that Cmax occurreddate_rangeTime 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 doseenhanced_encryptionNoSafety Issue:
- AUC0-12hArea under the serum amikacin concentration vs time curve from time 0 to 12 hdate_rangeTime 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 doseenhanced_encryptionNoSafety Issue:
- Xu0-12hAmount of amikacin excreted in urine from 0 to 12 h after dosingdate_rangeTime Frame:On Day 3 at the start of dose and up to 12 h after both first and second doseenhanced_encryptionNoSafety Issue:
- Xu12-24hAmount of amikacin excreted in urine from 12 to 24 h after dosingdate_rangeTime Frame:On Day 3 at the start of dose and up to 12 h after both first and second doseenhanced_encryptionNoSafety Issue:
- Xu0-24hAmount of amikacin excreted in urine from 0 to 24 h after dosingdate_rangeTime Frame:On Day 3 at the start of dose and up to 12 h after both first and second doseenhanced_encryptionNoSafety Issue:
- Tracheal aspiratedate_rangeTime Frame:Day 3enhanced_encryptionNoSafety Issue:
- Epithelial lining fluid (ELF) concentrationdate_rangeTime Frame:Approximately 15-30 min after completion of the morning dose of study medication on Day 3enhanced_encryptionNoSafety Issue:
Secondary Outcome
- Number of participants with adverse eventsdate_rangeTime Frame:Approximately 6 weeksenhanced_encryptionyesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
N/ABlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1Additional Information
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