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Nebulized Amikacin Versus Intravenous Amikacin in the Treatment of Nosocomial Pneumonia

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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

Tracking Information
First Submitted Date  ICMJE March 25, 2016
First Posted Date  ICMJE April 5, 2016
Last Update Posted Date August 25, 2016
Study Start Date  ICMJE August 2014
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 4, 2016)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nebulized Amikacin Versus Intravenous Amikacin in the Treatment of Nosocomial Pneumonia
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pneumonia
Intervention  ICMJE
  • Drug: Nebulized Amikacin
    400mg twice daily nebulized amikacin
  • Drug: Intravenous Amikacin
    20mg/kg once daily intravenous amikacin
Study Arms  ICMJE
  • Experimental: Nebulized Amikacin
    patients in this arm will take amikacin nebulizer 400 mg twice daily in addition to standard beta lactam
    Intervention: Drug: 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
    Intervention: Drug: Intravenous Amikacin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 23, 2016)
133
Original Actual Enrollment  ICMJE
 (submitted: April 4, 2016)
118
Actual Study Completion Date  ICMJE August 2015
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02728518
Other Study ID Numbers  ICMJE NHI-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party NKhalek, National Heart Institute, Egypt
Study Sponsor  ICMJE National Heart Institute, Egypt
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account National Heart Institute, Egypt
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP