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Nebulized Amikacin Versus Intravenous Amikacin in the Treatment of Nosocomial Pneumonia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02728518
Recruitment Status : Completed
First Posted : April 5, 2016
Last Update Posted : August 25, 2016
Sponsor:
Information provided by (Responsible Party):
NKhalek, National Heart Institute, Egypt

Study Description
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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

Condition or disease Intervention/treatment Phase
Pneumonia Drug: Nebulized Amikacin Drug: Intravenous Amikacin Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 133 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arms and Interventions
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Arm Intervention/treatment
Experimental: Nebulized Amikacin
patients in this arm will take amikacin nebulizer 400 mg twice daily in addition to standard beta lactam
 Drug: Nebulized Amikacin
400mg twice daily nebulized amikacin
Active Comparator: Amikacin Intravenous
patients in this arm will take intravenous (IV) amikacin 20 mg/kg once daily in addition to standard beta lactam
 Drug: Intravenous Amikacin
20mg/kg once daily intravenous amikacin


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02728518


Sponsors and Collaborators
National Heart Institute, Egypt
Investigators
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Principal Investigator: Nehal A Hassan, BCPS National Heart Institute
Principal Investigator: Faten F El sayed, MD National Heart Institute
Principal Investigator: Nirmeen A Sabry, Ph.D Faculty of Pharmacy Cairo University
More Information
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Responsible Party: NKhalek, Pharmacotherapy Specialist, National Heart Institute, Egypt
ClinicalTrials.gov Identifier: NCT02728518    
Other Study ID Numbers: NHI-01
First Posted: April 5, 2016    Key Record Dates
Last Update Posted: August 25, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
 Amikacin
Anti-Bacterial Agents
Anti-Infective Agents