NCT00697944

Ambisome® Preemptive Treatment of Multiple Candida Colonization in Sepsis Patients

Ambisome® Preemptive Treatment of Multiple Colonizations by Candida in Intensive Care Patients With a Sepsis

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Fovea · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Sepsis
• Candida

Interventions

Type	Name	Description
DRUG	Amphotericine in liposome (Ambisome®)	2 IV infusions separated by one week 10 mg/kg per injection

Timeline

• Start date: 2008-03-01
• Primary completion: 2009-02-01
• Completion: 2009-03-01
• First posted: 2008-06-16
• Last updated: 2008-06-16

Locations

2 sites across 1 country: France