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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-005079-17 | EudraCT Number |
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| Name | Class |
|---|---|
| Nektar Therapeutics | INDUSTRY |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amikacin inhalation solution | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amikacin inhalation solution (BAY41-6551) | Drug | Daily dose of 800 mg of aerosolized amikacin delivered in two divided doses of 400 mg per aerosol treatment 12 hour |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum serum amikacin concentration observed from time 0 to 12 h | 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 |
| Tmax | Time that Cmax occurred | 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 |
| AUC0-12h | Area under the serum amikacin concentration vs time curve from time 0 to 12 h | 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 |
| Xu0-12h | Amount of amikacin excreted in urine from 0 to 12 h after dosing | On Day 3 at the start of dose and up to 12 h after both first and second dose |
| Xu12-24h | Amount of amikacin excreted in urine from 12 to 24 h after dosing | On Day 3 at the start of dose and up to 12 h after both first and second dose |
| Xu0-24h | Amount of amikacin excreted in urine from 0 to 24 h after dosing | On Day 3 at the start of dose and up to 12 h after both first and second dose |
| Tracheal aspirate | Day 3 | |
| Epithelial lining fluid (ELF) concentration |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | Approximately 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birminghan | Alabama | 35233 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20003269 | Result | 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. doi: 10.1186/cc8206. Epub 2009 Dec 10. |
| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe. | View source |
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| Approximately 15-30 min after completion of the morning dose of study medication on Day 3 |
| Cincinnati |
| Ohio |
| 45267 |
| United States |
| Memphis | Tennessee | 38163 | United States |
| Houston | Texas | 77030 | United States |
| Paris | Cedex 13 | 75651 | France |
| Limoges | Cedex | 87046 | France |
| ID | Term |
|---|---|
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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