Nebulized Ceftazidime and Amikacin in Ventilator Associated Pneumonia

November 5, 2008 updated by: Groupe Hospitalier Pitie-Salpetriere

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75013
        • Intensive care unit, Department of anesthesiology, La pitie-Salpetriere hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • fortum and amiklin
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 Names:
  • fortum and amiklin
Active Comparator: 2: intravenous 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 Names:
  • fortum and amiklin
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 Names:
  • fortum and amiklin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bacterial killing
Time Frame: 14 days
14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes of lung aeration
Time Frame: 8 days
8 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Hospitalier Pitie-Salpetriere

Investigators

  • Principal Investigator: Jean-Jacques Rouby, MD, PhD, La pitié-Salpétrière Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

November 5, 2008

First Submitted That Met QC Criteria

November 5, 2008

First Posted (Estimate)

November 6, 2008

Study Record Updates

Last Update Posted (Estimate)

November 6, 2008

Last Update Submitted That Met QC Criteria

November 5, 2008

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NATB-2004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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