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Completed

NCT Number: NCT00786305

Nebulized Ceftazidime and Amikacin in Ventilator Associated Pneumonia

Pseudomonas aeruginosa is one of the major causative microorganisms of ventilator-associated pneumonia often resistant to antibiotics. In experimental models, nebulization of antibiotics delivers high lung tissue concentrations of antibiotics in infected lungs and increases lung bacterial killing. The aim of the study is to assess the efficiency of nebulized ceftazidime and amikacin in the treatment of pneumonia caused by Pseudomonas aeruginosa in ventilated patients.

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Key information

Conditions

Pneumonia Bacterial Infections Bacterial Infections and Mycoses Cross Infection Disease Attributes Gram-Negative Bacterial Infections Healthcare-Associated Pneumonia Iatrogenic Disease Infections Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia, Ventilator-Associated Pseudomonas Infections Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Intensive care unit, Department of anesthesiology, La pitie-Salpetriere hospital

Paris, 75013, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female >18 years old, ventilator associated pneumonia caused by pseudomonas aeruginosa
  • Written informed consent provided by the relatives

Exclusion criteria

  • Pseudomonas aeruginosa resistant to ceftazidime and amikacin
  • Pseudomonas aeruginosa pneumonia associated with other infections requiring intravenous treatment
  • Severe septic shock and severe hypoxemia
  • Allergy to ceftazidime or amikacin

Treatment and study plan

ceftazidime and amikacin

Drug

Nebulized ceftazidime 15 mg/kg/3h during 8 days and nebulized amikacin 25 mg/kg/day during 3 days

Other names: fortum and amiklin

Primary outcomes

  1. Bacterial killing

    Time frame: 14 days

Secondary outcomes

  1. Changes of lung aeration

    Time frame: 8 days

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier Pitie-Salpetriere

Other

Registry information

Official study title

Assessment of Efficiency of Nebulized Ceftazidime and Amikacin in Treatment of Ventilator Associated Pneumonia Caused by Pseudomonas Aeruginosa

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Nov 6, 2008
Registry last updated
Nov 6, 2008

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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