Ambisome® Preemptive Treatment of Multiple Candida Colonization in Sepsis Patients
Information source: Fovea
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sepsis; Candida
Intervention: Amphotericine in liposome (Ambisome®) (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Fovea Official(s) and/or principal investigator(s):
Elie AZOULAY, MD PhD, Principal Investigator, Affiliation: University Teaching Hospital Saint Louis, Paris
Overall contact:
Jean−François RI DREYFUS, MD PhD, Phone: 33-61-282-6780, Email: jfdreyfus@aol.com
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
Clinical Details
Official title: Ambisome® Preemptive Treatment of Multiple Colonizations by Candida in Intensive Care Patients With a Sepsis
Study design: Prevention, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Global assessment of severity of adverse events; incidence, severity and consequences of treatment emergent effects
Secondary outcome: Duration of stay in the intensive care unit; occurrence of a systemic fungal infection
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Jean−François RI DREYFUS, MD PhD, Phone: 33-61-282-6780, Email: jfdreyfus@aol.com
Hopital Saint Louis, PARIS 75010, France; Not yet recruiting
Chu Michallon, GRENOBLE 38000, France; Recruiting
TIMSIT, Email: jftimsit@chu-grenoble.fr
Additional Information
Starting date: March 2008
Ending date: March 2009
Last updated: June 13, 2008
|
