Trial | NCT02728518  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    amikacin ...

  • Study Participants

    133
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 Started
Aug 31
2014
Primary Completion
Aug 31
2015
Study Completion
Aug 31
2015
Last Update
Aug 25
2016
Estimate

Drug Nebulized Amikacin

400mg twice daily nebulized amikacin

Drug Intravenous Amikacin

20mg/kg once daily intravenous amikacin

Nebulized Amikacin Experimental

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

Amikacin Intravenous Active Comparator

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

Criteria 

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
No Results Posted