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| Sponsored by: |
Groupe Hospitalier Pitie-Salpetriere |
|---|---|
| Information provided by: | Groupe Hospitalier Pitie-Salpetriere |
| ClinicalTrials.gov Identifier: | NCT00786305 |
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 II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
| Official Title: | Assessment of Efficiency of Nebulized Ceftazidime and Amikacin in Treatment of Ventilator Associated Pneumonia Caused by Pseudomonas Aeruginosa |
| 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 |
|---|---|
| 1: nebulized ceftazidime and amikacin: Experimental |
Drug: ceftazidime and amikacin
Nebulized ceftazidime 15 mg/kg/3h during 8 days and nebulized amikacin 25 mg/kg/day during 3 days
|
| 2: intravenous ceftazidime and amikacin: Active Comparator |
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| France | |
| Intensive care unit, Department of anesthesiology, La pitie-Salpetriere hospital | |
| Paris, France, 75013 | |
| Principal Investigator: | Jean-Jacques Rouby, MD, PhD | La Pitie-Salpetriere hospital |
More Information
| Responsible Party: | Groupe Hospitalier Pitie-Salpetriere ( Jean-Jacques Rouby ) |
| Study ID Numbers: | NATB-2004 |
| Study First Received: | November 5, 2008 |
| Last Updated: | November 5, 2008 |
| ClinicalTrials.gov Identifier: | NCT00786305 History of Changes |
| Health Authority: | France: Afssaps - French Health Products Safety Agency |
|
Nebulization ceftazidime amikacin pneumonia |
Pseudomonas aeruginosa mechanical ventilation Ventilator-associated pneumonia treatment |
|
Ceftazidime Anti-Bacterial Agents Amikacin Respiratory Tract Infections Respiratory Tract Diseases |
Lung Diseases Pneumonia, Ventilator-Associated Cross Infection Pneumonia |
|
Anti-Infective Agents Amikacin Infection Pneumonia, Ventilator-Associated Pharmacologic Actions Ceftazidime Anti-Bacterial Agents |
Respiratory Tract Diseases Respiratory Tract Infections Lung Diseases Therapeutic Uses Pneumonia Cross Infection |
