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Nebulized Ceftazidime and Amikacin in Ventilator Associated Pneumonia

Primary Purpose

Pneumonia

Status

Completed

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

ceftazidime and amikacin

About this trial

This is an interventional treatment trial for Pneumonia focused on measuring Nebulization, ceftazidime, amikacin, pneumonia, Pseudomonas aeruginosa, mechanical ventilation, Ventilator-associated pneumonia, treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1: nebulized ceftazidime and amikacin

2: intravenous ceftazidime and amikacin

Arm Description

Outcomes

Primary Outcome Measures

Bacterial killing

Secondary Outcome Measures

Changes of lung aeration

Full Information

NCT ID

NCT00786305

First Posted

November 5, 2008

Last Updated

November 5, 2008

Sponsor

Groupe Hospitalier Pitie-Salpetriere

1. Study Identification

Unique Protocol Identification Number

NCT00786305

Brief Title

Nebulized Ceftazidime and Amikacin in Ventilator Associated Pneumonia

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2008

Overall Recruitment Status

Completed

Study Start Date

October 2004 (undefined)

Primary Completion Date

September 2008 (Actual)

Study Completion Date

November 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Groupe Hospitalier Pitie-Salpetriere

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pneumonia

Keywords

Nebulization, ceftazidime, amikacin, pneumonia, Pseudomonas aeruginosa, mechanical ventilation, Ventilator-associated pneumonia, treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1: nebulized ceftazidime and amikacin

Arm Type

Experimental

Arm Title

2: intravenous ceftazidime and amikacin

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

ceftazidime and amikacin

Other Intervention Name(s)

fortum and amiklin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

ceftazidime and amikacin

Other Intervention Name(s)

fortum and amiklin

Intervention Description

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

Primary Outcome Measure Information:

Title

Bacterial killing

Time Frame

14 days

Secondary Outcome Measure Information:

Title

Changes of lung aeration

Time Frame

8 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jean-Jacques Rouby, MD, PhD

Organizational Affiliation

La Pitie-Salpetriere hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Paris

ZIP/Postal Code

75013

Country

France

12. IPD Sharing Statement

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Nebulized Ceftazidime and Amikacin in Ventilator Associated Pneumonia

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