Ambisome® Preemptive Treatment of Multiple Candida Colonization in Sepsis Patients

Fovea30 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Sepsis Candida

Interventions

Amphotericine in liposome (Ambisome®)DRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 (2)

Chu Michallon

Grenoble, France

RECRUITING

Hopital Saint Louis

Paris, France

NOT_YET_RECRUITING

Outcomes

Primary Outcomes

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

Time frame: 28-day observation period

Secondary Outcomes

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

Time frame: 28 days after first treatment administration

Central Contacts

Jean-François RI DREYFUS, MD PhD

CONTACT

33-61-282-6780 jfdreyfus@aol.com

Data from ClinicalTrials.gov

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