Status:
UNKNOWN
Ambisome® Preemptive Treatment of Multiple Candida Colonization in Sepsis Patients
Lead Sponsor:
Fovea
Collaborating Sponsors:
Gilead Sciences
Conditions:
Sepsis
Candida
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00697944
Start Date
March 1 2008
End Date
March 1 2009
Last Update
June 16 2008
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Chu Michallon
Grenoble, France, 38000
2
Hopital Saint Louis
Paris, France, 75010