Ambisome® Preemptive Treatment of Multiple Candida Colonization in Sepsis Patients (AMBIDEX)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00697944|
Recruitment Status : Unknown
Verified March 2009 by Fovea.
Recruitment status was: Recruiting
First Posted : June 16, 2008
Last Update Posted : June 16, 2008
To assess the safety of Ambisome 10 mg/kg/week in patients as a preemptive treatment in intensive care patients with a sepsis and rising candida colonisation.
Preemptive treatment (i.e., prophylactic treatment with two high doses of Ambisome® administered with an interval of one week, in patiens with a high risk of developing a fungal infection) should decrease the incidence of actual systemic infections.
The incidence of such actual fungal infections will be assessed directly and its impact on patients' survival and intensive care resourches assessed
|Condition or disease||Intervention/treatment||Phase|
|Sepsis Candida||Drug: Amphotericine in liposome (Ambisome®)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Ambisome® Preemptive Treatment of Multiple Colonizations by Candida in Intensive Care Patients With a Sepsis|
|Study Start Date :||March 2008|
|Estimated Primary Completion Date :||February 2009|
|Estimated Study Completion Date :||March 2009|
- Drug: Amphotericine in liposome (Ambisome®)
2 IV infusions separated by one week 10 mg/kg per injection
- Global assessment of severity of adverse events; incidence, severity and consequences of treatment emergent effects [ Time Frame: 28−day observation period ]
- Duration of stay in the intensive care unit; occurrence of a systemic fungal infection [ Time Frame: 28 days after first treatment administration ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00697944
|Contact: Jean−François RI DREYFUS, MD PhDfirstname.lastname@example.org|
|Grenoble, France, 38000|
|Contact: TIMSIT email@example.com|
|Hopital Saint Louis||Not yet recruiting|
|Paris, France, 75010|
|Principal Investigator:||Elie AZOULAY, MD PhD||University Teaching Hospital Saint Louis, Paris|