Nebulized Amikacin Versus Intravenous Amikacin in the Treatment of Nosocomial Pneumonia

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02728518

Enrollment

133

Registered

2016-04-05

Start date

2014-08-31

Completion date

2015-08-31

Last updated

2016-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumonia

Brief summary

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

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.

Interventions

DRUGNebulized Amikacin

400mg twice daily nebulized amikacin

DRUGIntravenous Amikacin

20mg/kg once daily intravenous amikacin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026