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Nebulized Ceftazidime and Amikacin in Ventilator Associated Pneumonia

This study has been completed.
Sponsor:
Information provided by:
Groupe Hospitalier Pitie-Salpetriere
ClinicalTrials.gov Identifier:
NCT00786305
First received: November 5, 2008
Last updated: NA
Last verified: November 2008
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Pneumonia
 Drug: ceftazidime and amikacin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Assessment of Efficiency of Nebulized Ceftazidime and Amikacin in Treatment of Ventilator Associated Pneumonia Caused by Pseudomonas Aeruginosa

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Groupe Hospitalier Pitie-Salpetriere:

Primary Outcome Measures:
  • Bacterial killing [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Changes of lung aeration [ Time Frame: 8 days ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: October 2004
Study Completion Date: November 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: fortum and amiklin
Active Comparator: 2: intravenous ceftazidime and amikacin 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 Name: fortum and amiklin

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00786305

Locations
France
Intensive care unit, Department of anesthesiology, La pitie-Salpetriere hospital
Paris, France, 75013
Sponsors and Collaborators
Groupe Hospitalier Pitie-Salpetriere
Investigators
Principal Investigator: Jean-Jacques Rouby, MD, PhD La Pitie-Salpetriere hospital
  More Information

No publications provided

Responsible Party: Jean-Jacques Rouby, Groupe Hospitalier Pitie-Salpetriere
ClinicalTrials.gov Identifier: NCT00786305     History of Changes
Other Study ID Numbers: NATB-2004
Study First Received: November 5, 2008
Last Updated: November 5, 2008
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Groupe Hospitalier Pitie-Salpetriere:
Nebulization
ceftazidime
amikacin
pneumonia
 Pseudomonas aeruginosa
mechanical ventilation
Ventilator-associated pneumonia
treatment

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection
Ventilator-Induced Lung Injury
 Lung Injury
Amikacin
Ceftazidime
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013