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Ambisome® Preemptive Treatment of Multiple Candida Colonization in Sepsis Patients (AMBIDEX)

Primary Purpose

Sepsis, Candida

Status
Unknown status
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Amphotericine in liposome (Ambisome®)
Sponsored by
Fovea
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sepsis focused on measuring FUNGAL INFECTION, SEPSIS, INTENSIVE CARE, AMBISOME, PREEMPTIVE TREATMENT, Sepsis with candida colonisation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chu MichallonRecruiting
  • Hopital Saint Louis

Outcomes

Primary Outcome Measures

Global assessment of severity of adverse events; incidence, severity and consequences of treatment emergent effects

Secondary Outcome Measures

Duration of stay in the intensive care unit; occurrence of a systemic fungal infection

Full Information

First Posted
June 12, 2008
Last Updated
June 13, 2008
Sponsor
Fovea
Collaborators
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00697944
Brief Title
Ambisome® Preemptive Treatment of Multiple Candida Colonization in Sepsis Patients
Acronym
AMBIDEX
Official Title
Ambisome® Preemptive Treatment of Multiple Colonizations by Candida in Intensive Care Patients With a Sepsis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Unknown status
Study Start Date
March 2008 (undefined)
Primary Completion Date
February 2009 (Anticipated)
Study Completion Date
March 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Fovea
Collaborators
Gilead Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Candida
Keywords
FUNGAL INFECTION, SEPSIS, INTENSIVE CARE, AMBISOME, PREEMPTIVE TREATMENT, Sepsis with candida colonisation

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Amphotericine in liposome (Ambisome®)
Intervention Description
2 IV infusions separated by one week 10 mg/kg per injection
Primary Outcome Measure Information:
Title
Global assessment of severity of adverse events; incidence, severity and consequences of treatment emergent effects
Time Frame
28-day observation period
Secondary Outcome Measure Information:
Title
Duration of stay in the intensive care unit; occurrence of a systemic fungal infection
Time Frame
28 days after first treatment administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-François RI DREYFUS, MD PhD
Phone
33-61-282-6780
Email
jfdreyfus@aol.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elie AZOULAY, MD PhD
Organizational Affiliation
University Teaching Hospital Saint Louis, Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Michallon
City
Grenoble
ZIP/Postal Code
38000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
TIMSIT
Email
jftimsit@chu-grenoble.fr
Facility Name
Hopital Saint Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Citations:
PubMed Identifier
28531175
Citation
Azoulay E, Timsit JF, Lautrette A, Legriel S, Max A, Ruckly S, Misset B, Cohen Y, Wolff M. Weekly high-dose liposomal amphotericin B (L-AmB) in critically ill septic patients with multiple Candida colonization: The AmBiDex study. PLoS One. 2017 May 22;12(5):e0177093. doi: 10.1371/journal.pone.0177093. eCollection 2017.
Results Reference
derived

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Ambisome® Preemptive Treatment of Multiple Candida Colonization in Sepsis Patients

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