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Completed

NCT Number: NCT02728518

Nebulized Amikacin Versus Intravenous Amikacin in the Treatment of Nosocomial Pneumonia

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

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Key information

Conditions

Pneumonia Infections Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nebulized Amikacin

Drug

400mg twice daily nebulized amikacin

Intravenous Amikacin

Drug

20mg/kg once daily intravenous amikacin

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

National Heart Institute, Egypt

Other Gov

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 5, 2016
Registry last updated
Aug 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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