Nebulized Amikacin Versus Intravenous Amikacin in the Treatment of Nosocomial Pneumonia

Pneumonia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02728518
• Other study ID #: NHI-01
• Status: Completed
• Phase: N/A
• First received: March 25, 2016
• Last updated: August 23, 2016
• Start date: August 2014
• Est. completion date: August 2015

Study information

• Verified date: August 2016
• Source: National Heart Institute, Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pneumonia

Intervention

Drug:
• Nebulized Amikacin
400mg twice daily nebulized amikacin
• Intravenous Amikacin
20mg/kg once daily intravenous amikacin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Heart Institute, Egypt

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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