Nebulized Ceftazidime and Amikacin in Ventilator Associated Pneumonia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2008-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1: nebulized ceftazidime and amikacin

Group Type EXPERIMENTAL

ceftazidime and amikacin

Intervention Type DRUG

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

2: intravenous ceftazidime and amikacin

Group Type ACTIVE_COMPARATOR

ceftazidime and amikacin

Intervention Type DRUG

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

Interventions

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ceftazidime and amikacin

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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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fortum and amiklin fortum and amiklin

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No