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Nebulized Ceftazidime and Amikacin in Ventilator Associated Pneumonia

This study has been completed.
Information provided by:
Groupe Hospitalier Pitie-Salpetriere Identifier:
First received: November 5, 2008
Last updated: NA
Last verified: November 2008
History: No changes posted
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.

Condition Intervention Phase
Drug: ceftazidime and amikacin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Assessment of Efficiency of Nebulized Ceftazidime and Amikacin in Treatment of Ventilator Associated Pneumonia Caused by Pseudomonas Aeruginosa

Resource links provided by NLM:

Further study details as provided by Groupe Hospitalier Pitie-Salpetriere:

Primary Outcome Measures:
  • Bacterial killing [ Time Frame: 14 days ]

Secondary Outcome Measures:
  • Changes of lung aeration [ Time Frame: 8 days ]

Enrollment: 40
Study Start Date: October 2004
Study Completion Date: November 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1: nebulized ceftazidime and amikacin Drug: ceftazidime and amikacin
Nebulized ceftazidime 15 mg/kg/3h during 8 days and nebulized amikacin 25 mg/kg/day during 3 days
Other Name: fortum and amiklin
Active Comparator: 2: intravenous ceftazidime and amikacin Drug: ceftazidime and amikacin
Intravenous infusion of ceftazidime 30 mg/kg over 30 min followed by continuous infusion 90 mg/kg/day during 8 days and intravenous infusion of amikacin 15 mg/kg/day over 30 min during 3 days
Other Name: fortum and amiklin


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00786305

Intensive care unit, Department of anesthesiology, La pitie-Salpetriere hospital
Paris, France, 75013
Sponsors and Collaborators
Groupe Hospitalier Pitie-Salpetriere
Principal Investigator: Jean-Jacques Rouby, MD, PhD La Pitie-Salpetriere hospital
  More Information

Responsible Party: Jean-Jacques Rouby, Groupe Hospitalier Pitie-Salpetriere Identifier: NCT00786305     History of Changes
Other Study ID Numbers: NATB-2004
Study First Received: November 5, 2008
Last Updated: November 5, 2008

Keywords provided by Groupe Hospitalier Pitie-Salpetriere:
Pseudomonas aeruginosa
mechanical ventilation
Ventilator-associated pneumonia

Additional relevant MeSH terms:
Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Ventilator-Induced Lung Injury
Lung Injury
Anti-Bacterial Agents
Anti-Infective Agents processed this record on May 25, 2017