Nebulized Amikacin Versus Intravenous Amikacin in the Treatment of Nosocomial Pneumonia

August 23, 2016 updated by: NKhalek, National Heart Institute, Egypt

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

133

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nebulized Amikacin
patients in this arm will take amikacin nebulizer 400 mg twice daily in addition to standard beta lactam
Drug: Nebulized Amikacin
400mg twice daily 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
Drug: Intravenous Amikacin
20mg/kg once daily intravenous amikacin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
through study completion, over one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Heart Institute, Egypt

Investigators

  • 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

March 25, 2016

First Submitted That Met QC Criteria

April 4, 2016

First Posted (Estimate)

April 5, 2016

Study Record Updates

Last Update Posted (Estimate)

August 25, 2016

Last Update Submitted That Met QC Criteria

August 23, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NHI-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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