AMBIDEX: Ambisome® Preemptive Treatment of Multiple Candida Colonization in Sepsis Patients

Sponsor

Fovea (Other)

Overall Status

Unknown status

CT.gov ID

NCT00697944

Collaborator

Gilead Sciences (Industry)

Enrollment

Locations

Duration (Months)

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Sepsis Candida	Drug: Amphotericine in liposome (Ambisome®)	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Mar 1, 2008

Anticipated Primary Completion Date :

Feb 1, 2009

Anticipated Study Completion Date :

Mar 1, 2009

Outcome Measures

Primary Outcome Measures

Global assessment of severity of adverse events; incidence, severity and consequences of treatment emergent effects [28-day observation period]

Secondary Outcome Measures

Duration of stay in the intensive care unit; occurrence of a systemic fungal infection [28 days after first treatment administration]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Supportive mechanical ventilation for more than 48 h
LOD > 5 with with ailing body systems
Candida colonisation of at least one site in addition to the digestive tract
Suspected nosocomial infection with antibiotic treatment
Informed consent

Exclusion Criteria:

Patients treated with oral or systemic antifungal agents within 15 days prior to inclusion
Patients requiring treatment with an antifungal agent or with a documented (proven or probable) fungal infection according to the EORTC criteria
Patients with a SAPS score > 65
Patients with neutropenia of that underwent a bone marrow tar organ transplant or with cancer chemotherapy
Blood creatinine > 220 µmol/L
Hemodyalysis
Pregnant women