Nebulized Ceftazidime and Amikacin in Ventilator Associated Pneumonia

Groupe Hospitalier Pitie-Salpetriere

Status and phase: Completed; Phase 2

Conditions: Pneumonia

Treatments: Drug: ceftazidime and amikacin

Study type: Interventional

Funder types: Other

Identifiers

NCT00786305

NATB-2004

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

1: nebulized ceftazidime and amikacin

Experimental group

Treatment:

Drug: ceftazidime and amikacin

Drug: ceftazidime and amikacin

2: intravenous ceftazidime and amikacin

Active Comparator group

Treatment:

Drug: ceftazidime and amikacin

Drug: ceftazidime and amikacin