- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00697944
Ambisome® Preemptive Treatment of Multiple Candida Colonization in Sepsis Patients (AMBIDEX)
Ambisome® Preemptive Treatment of Multiple Colonizations by Candida in Intensive Care Patients With a Sepsis
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 Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Jean-François RI DREYFUS, MD PhD
- Phone Number: 33-61-282-6780
- Email: jfdreyfus@aol.com
Study Locations
-
-
-
Grenoble, France, 38000
- Recruiting
- CHU Michallon
-
Contact:
- TIMSIT
- Email: jftimsit@chu-grenoble.fr
-
Paris, France, 75010
- Not yet recruiting
- Hopital Saint Louis
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Global assessment of severity of adverse events; incidence, severity and consequences of treatment emergent effects
Time Frame: 28-day observation period
|
28-day observation period
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Duration of stay in the intensive care unit; occurrence of a systemic fungal infection
Time Frame: 28 days after first treatment administration
|
28 days after first treatment administration
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Elie AZOULAY, MD PhD, University Teaching Hospital Saint Louis, Paris
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AMBIDEX
- EUDRA-CT 2007-004444-71
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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