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Nebulized Ceftazidime and Amikacin in Ventilator Associated Pneumonia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00786305
First Posted: November 6, 2008
Last Update Posted: November 6, 2008
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.
Information provided by:
Groupe Hospitalier Pitie-Salpetriere
  Purpose
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
Pneumonia Drug: ceftazidime and amikacin Phase 2

Study Type: Interventional
Study Design: 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

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

  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00786305


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

Responsible Party: Jean-Jacques Rouby, Groupe Hospitalier Pitie-Salpetriere
ClinicalTrials.gov Identifier: NCT00786305     History of Changes
Other Study ID Numbers: NATB-2004
First Submitted: November 5, 2008
First Posted: November 6, 2008
Last Update Posted: November 6, 2008
Last Verified: November 2008

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

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection
Ventilator-Induced Lung Injury
Lung Injury
Amikacin
Ceftazidime
Anti-Bacterial Agents
Anti-Infective Agents