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Nebulized Amikacin Versus Intravenous Amikacin in the Treatment of Nosocomial Pneumonia

Primary Purpose

Pneumonia

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Nebulized Amikacin

Intravenous Amikacin

About this trial

This is an interventional treatment trial for Pneumonia

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nebulized Amikacin

Amikacin Intravenous

Arm Description

patients in this arm will take amikacin nebulizer 400 mg twice daily in addition to standard beta lactam

patients in this arm will take intravenous (IV) amikacin 20 mg/kg once daily in addition to standard beta lactam

Outcomes

Primary Outcome Measures

Proportion of cured patients in the nebulized amikacin group versus the proportion of cured patients in the intravenous group

Secondary Outcome Measures

Full Information

NCT ID

NCT02728518

First Posted

March 25, 2016

Last Updated

August 23, 2016

Sponsor

National Heart Institute, Egypt

1. Study Identification

Unique Protocol Identification Number

NCT02728518

Brief Title

Nebulized Amikacin Versus Intravenous Amikacin in the Treatment of Nosocomial Pneumonia

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 Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Completed

Study Start Date

August 2014 (undefined)

Primary Completion Date

August 2015 (Actual)

Study Completion Date

August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National Heart Institute, Egypt

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pneumonia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

133 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nebulized Amikacin

Arm Type

Experimental

Arm Description

patients in this arm will take amikacin nebulizer 400 mg twice daily in addition to standard beta lactam

Arm Title

Amikacin Intravenous

Arm Type

Active Comparator

Arm Description

patients in this arm will take intravenous (IV) amikacin 20 mg/kg once daily in addition to standard beta lactam

Intervention Type

Drug

Intervention Name(s)

Nebulized Amikacin

Intervention Description

400mg twice daily nebulized amikacin

Intervention Type

Drug

Intervention Name(s)

Intravenous Amikacin

Intervention Description

20mg/kg once daily intravenous amikacin

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nehal A Hassan, BCPS

Organizational Affiliation

National Heart Institute

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Faten F El sayed, MD

Organizational Affiliation

National Heart Institute

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Nirmeen A Sabry, Ph.D

Organizational Affiliation

Faculty of Pharmacy Cairo University

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Nebulized Amikacin Versus Intravenous Amikacin in the Treatment of Nosocomial Pneumonia

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