Nebulized Ceftazidime and Amikacin in Ventilator Associated Pneumonia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00786305
Recruitment Status : Completed
First Posted : November 6, 2008
Last Update Posted : November 6, 2008
Information provided by:
Groupe Hospitalier Pitie-Salpetriere

Brief Summary:
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 or disease Intervention/treatment Phase
Pneumonia Drug: ceftazidime and amikacin Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : October 2004
Primary Completion Date : September 2008
Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia
U.S. FDA Resources

Arm Intervention/treatment
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

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

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

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Jean-Jacques Rouby, Groupe Hospitalier Pitie-Salpetriere Identifier: NCT00786305     History of Changes
Other Study ID Numbers: NATB-2004
First Posted: November 6, 2008    Key Record Dates
Last Update Posted: November 6, 2008
Last Verified: November 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