Nebulized Amikacin Versus Intravenous Amikacin in the Treatment of Nosocomial Pneumonia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

133 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2015-08-31

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

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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.

Conditions

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Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nebulized Amikacin

patients in this arm will take amikacin nebulizer 400 mg twice daily in addition to standard beta lactam

Group Type EXPERIMENTAL

Nebulized Amikacin

Intervention Type DRUG

400mg twice daily nebulized amikacin

Amikacin Intravenous

patients in this arm will take intravenous (IV) amikacin 20 mg/kg once daily in addition to standard beta lactam

Group Type ACTIVE_COMPARATOR

Intravenous Amikacin

Intervention Type DRUG

20mg/kg once daily intravenous amikacin

Interventions

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Nebulized Amikacin

400mg twice daily nebulized amikacin

Intervention Type DRUG

Intravenous Amikacin

20mg/kg once daily intravenous amikacin

Intervention Type DRUG

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

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No