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Ambisome® Preemptive Treatment of Multiple Candida Colonization in Sepsis Patients

NCT00697944 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2008-06-16

No results posted yet for this study

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

Conditions

Interventions

DRUG

Amphotericine in liposome (Ambisome®)

2 IV infusions separated by one week 10 mg/kg per injection

Sponsors & Collaborators

Principal Investigators

  • Elie AZOULAY, MD PhD · University Teaching Hospital Saint Louis, Paris

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2009-02-28
Completion
2009-03-31

Countries

  • France

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00697944 on ClinicalTrials.gov