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

June 13, 2008 updated by: Fovea

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

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France, 38000
      • Paris, France, 75010
        • Not yet recruiting
        • Hopital Saint Louis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Sponsor

Fovea

Collaborators

Gilead Sciences

Investigators

  • Principal Investigator: Elie AZOULAY, MD PhD, University Teaching Hospital Saint Louis, Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Anticipated)

February 1, 2009

Study Completion (Anticipated)

March 1, 2009

Study Registration Dates

First Submitted

June 12, 2008

First Submitted That Met QC Criteria

June 13, 2008

First Posted (Estimate)

June 16, 2008

Study Record Updates

Last Update Posted (Estimate)

June 16, 2008

Last Update Submitted That Met QC Criteria

June 13, 2008

Last Verified

March 1, 2009

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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