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
1 other identifier
interventional
133
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2014
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 25, 2016
CompletedFirst Posted
Study publicly available on registry
April 5, 2016
CompletedAugust 25, 2016
August 1, 2016
1 year
March 25, 2016
August 23, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Nebulized Amikacin
EXPERIMENTALpatients in this arm will take amikacin nebulizer 400 mg twice daily in addition to standard beta lactam
Amikacin Intravenous
ACTIVE COMPARATORpatients in this arm will take intravenous (IV) amikacin 20 mg/kg once daily in addition to standard beta lactam
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Pharmacotherapy Specialist
Study Record Dates
First Submitted
March 25, 2016
First Posted
April 5, 2016
Study Start
August 1, 2014
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
August 25, 2016
Record last verified: 2016-08