Nebulized Amikacin Versus Intravenous Amikacin in the Treatment of Nosocomial Pneumonia

National Heart Institute, Egypt133 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

133

Conditions

Pneumonia

Interventions

Nebulized AmikacinDRUG

400mg twice daily nebulized amikacin

Intravenous AmikacinDRUG

20mg/kg once daily intravenous amikacin

Eligibility

Sex: ALLMin age: 21 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Proportion of cured patients in the nebulized amikacin group versus the proportion of cured patients in the intravenous group

Time frame: through study completion, over one year

Data from ClinicalTrials.gov

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