Nebulized Ceftazidime and Amikacin in Ventilator Associated Pneumonia

Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00786305
• Other study ID #: NATB-2004
• Status: Completed
• Phase: Phase 2
• First received: November 5, 2008
• Last updated: November 5, 2008
• Start date: October 2004
• Est. completion date: November 2008

Study information

• Verified date: November 2008
• Source: Groupe Hospitalier Pitie-Salpetriere
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Ventilator-Associated

Intervention

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

Locations

Country	Name	City	State
France	Intensive care unit, Department of anesthesiology, La pitie-Salpetriere hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Pitie-Salpetriere

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bacterial killing		14 days	Yes
Secondary	Changes of lung aeration		8 days	Yes