Ambisome® Preemptive Treatment of Multiple Candida Colonization in Sepsis Patients

Phase 4

• Conditions: Sepsis; Candida

• Registration Number: NCT00697944
• Lead Sponsor: Fovea

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-06-12
• Study First Submitted QC: 2008-06-13
• Last Update Submitted: 2008-06-13
• Study First Posted: 2008-06-16
• Last Update Posted: 2008-06-16
• Primary Completion: 2009-02
• Status Verified: 2009-03
• Study Completion: 2009-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Global assessment of severity of adverse events; incidence, severity and consequences of treatment emergent effects	28-day observation period

Secondary Outcome Measures

Name	Time	Method
Duration of stay in the intensive care unit; occurrence of a systemic fungal infection	28 days after first treatment administration

Trial Locations

Locations (2)

Chu Michallon; 🇫🇷 Grenoble, France

Hopital Saint Louis; 🇫🇷 Paris, France