Nebulized Amikacin Versus Intravenous Amikacin in the Treatment of Nosocomial Pneumonia

National Heart Institute, Egypt

Status

Completed

Conditions

Pneumonia

Treatments

Drug: Nebulized Amikacin

Drug: Intravenous Amikacin

Study type

Interventional

Funder types

Other

Identifiers

NCT02728518

NHI-01

Details and patient eligibility

About

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

Full 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.

Enrollment

133 patients

Sex

All

Ages

21 to 65 years old

Volunteers

No 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