Nebulized Amikacin Versus Intravenous Amikacin in the Treatment of Nosocomial Pneumonia

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Evaluation of the Safety and Efficacy of Nebulized Amikacin as Adjunctive Therapy in Hospital Acquired and Ventilator Associated Bacterial Pneumonia in Surgical Intensive Care Units

Conditions
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Pneumonia

Intervention / Treatment
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* Drug: Nebulized Amikacin
* Drug: Intravenous Amikacin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients admitted to ICU Clinical suspicion of VAP or HAP defined by a new persistent radiological infiltrate and one of the following signs: purulent tracheal aspirations, or temperature of 38° or higher, or leucocyte count > 10000/ml or Positive culture sensitive to amikacin In case of empirical treatment, risk of multi resistant bacteria defined as follows: Antimicrobial therapy in preceding 90 days and Current hospitalization of 5 d or more Exclusion Criteria: History of Asthma Multi organ failure or any psychiatric illness allergy to amikacin or intolerance to nebulized amikacin Myasthenia gravis. Severely impaired renal function (creatinine clearance lower than 10 mL/min or renal replacement therapy) Vestibulo-cochlear disease. Pregnancy. Brain death

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nebulized Amikacin<br>patients in this arm will take amikacin nebulizer 400 mg twice daily in addition to standard beta lactam | Drug: Nebulized Amikacin<br>* 400mg twice daily nebulized amikacin<br>|
| Active Comparator: Amikacin Intravenous<br>patients in this arm will take intravenous (IV) amikacin 20 mg/kg once daily in addition to standard beta lactam | Drug: Intravenous Amikacin<br>* 20mg/kg once daily intravenous amikacin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |