Candida, Sepsis
Conditions
Keywords
FUNGAL INFECTION, SEPSIS, INTENSIVE CARE, AMBISOME, PREEMPTIVE TREATMENT, Sepsis with candida colonisation
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
Interventions
2 IV infusions separated by one week 10 mg/kg per injection
Sponsors
Gilead Sciences
Fovea
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Global assessment of severity of adverse events; incidence, severity and consequences of treatment emergent effects | 28-day observation period |
Secondary
| Measure | Time frame |
|---|---|
| Duration of stay in the intensive care unit; occurrence of a systemic fungal infection | 28 days after first treatment administration |
Countries
France
Contacts
Primary ContactJean-François RI DREYFUS, MD PhD
Outcome results
None listed