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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 133
- Primary Endpoint
- Proportion of cured patients in the nebulized amikacin group versus the proportion of cured patients in the intravenous group
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Nebulized Amikacin
patients in this arm will take amikacin nebulizer 400 mg twice daily in addition to standard beta lactam
Intervention: Nebulized Amikacin (Drug)
Amikacin Intravenous
patients in this arm will take intravenous (IV) amikacin 20 mg/kg once daily in addition to standard beta lactam
Intervention: Intravenous Amikacin (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
NKhalek
Pharmacotherapy Specialist
National Heart Institute, Egypt