Trial | NCT00697944  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    amphotericin b ...

  • Study Participants

    30
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
Study Started
Mar 31
2008
Primary Completion
Feb 28
2009
Anticipated
Study Completion
Mar 31
2009
Anticipated
Last Update
Jun 16
2008
Estimate

Drug Amphotericine in liposome (Ambisome®)

2 IV infusions separated by one week 10 mg/kg per injection

Criteria 

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
No Results Posted