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The investigator's goal in this study is to evaluate the efficacy and safety of nebulized amikacin versus intravenous amikacin in patients with hospital and ventilator acquired pneumonia in surgical patients admitted to the intensive care units infected with gram negative bacilli
prospective, randomized, controlled study on post-cardiac surgery patients , included two groups, over one year period. The first group was administered intravenous (IV) amikacin 20 mg/kg once daily. The second group was prescribed amikacin nebulizer 400 mg twice daily. Both groups were co-administered intravenous (IV) piperacillin/tazobactam empirically.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nebulized Amikacin | Experimental | patients in this arm will take amikacin nebulizer 400 mg twice daily in addition to standard beta lactam |
|
| Amikacin Intravenous | Active Comparator | patients in this arm will take intravenous (IV) amikacin 20 mg/kg once daily in addition to standard beta lactam |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nebulized Amikacin | Drug | 400mg twice daily nebulized amikacin |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of cured patients in the nebulized amikacin group versus the proportion of cured patients in the intravenous group | through study completion, over one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nehal A Hassan, BCPS | National Heart Institute | Principal Investigator |
| Faten F El sayed, MD | National Heart Institute | Principal Investigator |
| Nirmeen A Sabry, Ph.D | Faculty of Pharmacy Cairo University | Principal Investigator |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 16, 2017 | |
| Reset | Oct 17, 2017 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 16, 2017 | Oct 17, 2017 |
| ID | Term |
|---|---|
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| Intravenous Amikacin |
| Drug |
20mg/kg once daily intravenous amikacin |
|