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| Name | Class |
|---|---|
| Nektar Therapeutics | INDUSTRY |
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This study is part of a research program too see if amikacin delivered as an aerosol directly to the lungs in combination with IV antibiotic therapy can help intubated patients with gram-negative pneumonia get better faster than when given intravenous antibiotics alone. The primary purpose of this study is to determine the correct dose of amikacin which is delivered directly to the lungs as an aerosol via an investigational device called the Pulmonary Delivery Device System (PDDS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Experimental |
| |
| Arm 3 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amikacin (BAY41-6551) | Drug | Single daily dose of 400 mg aerosolized amikacin and a single dose of aerosolized placebo on a rotating every 12hr schedule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients who achieve a C(max) for amikacin in tracheal aspirates at least 25 times greater than the reference MIC for hospital-acquired organisms and an AUC (0-24 hr) / MIC ratio that is 100 or greater on Day 1 | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean C(max) and mean AUC of amikacin in tracheal aspirates | Day 1 and Day 3 of treatment period | |
| Mean ratio of C (max) / MIC and mean ratio of AUC (0-24 hr) / MIC | Day 1 and Day 3 of treatment period |
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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 |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35233 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22147112 | Derived | Niederman MS, Chastre J, Corkery K, Fink JB, Luyt CE, Garcia MS. BAY41-6551 achieves bactericidal tracheal aspirate amikacin concentrations in mechanically ventilated patients with Gram-negative pneumonia. Intensive Care Med. 2012 Feb;38(2):263-71. doi: 10.1007/s00134-011-2420-0. Epub 2011 Dec 7. |
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| Amikacin (BAY41-6551) | Drug | Daily dose of 800 mg aerosolized amikacin delivered in two divided doses of 400 mg per aerosol treatment every 12hr |
|
| Placebo | Drug | Two aerosol treatments per day (one treatment every 12hr) |
|
| Clinical cure rate | Test of cure visit (7 days post last treatment dose) |
| Microbiological eradication rate of identified pathogens | Test of cure visit (7 days post last treatment dose) |
| Microbiological persistence rate | Test of cure visit (7 days post last treatment dose) |
| New infection rate | Test of cure visit (7 days post last treatment dose) |
| Assessment of adverse events related to drug or device | Treatment period, early post treatment period, test of cure visit, and late post treatment |
| Assessment of abnormal laboratory values | Treatment period, early post treatment period, test of cure visit, and late post treatment |
| Melbourne |
| Florida |
| 32901 |
| United States |
| Albany | New York | 12208 | United States |
| Winston-Salem | North Carolina | 27157 | United States |
| Columbus | Ohio | 43210 | United States |
| Houston | Texas | 77030 | United States |
| San Antonio | Texas | 78229 | United States |
| Angers | 49933 | France |
| Limoges | 87046 | France |
| Paris | 75018 | France |
| Paris | 75651 | France |
| Paris | 75674 | France |
| Paris | 75908 | France |
| Rouen | 76031 | France |
| Barcelona | 08003 | Spain |
| Barcelona | 08036 | Spain |
| Madrid | 28034 | Spain |
| Madrid | 28040 | Spain |
| Madrid | 28805 | Spain |
| Murcia | 30120 | Spain |
| ID | Term |
|---|---|
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000583 | Amikacin |
| ID | Term |
|---|---|
| D007612 | Kanamycin |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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