Ambisome® Preemptive Treatment of Multiple Candida Colonization in Sepsis Patients

Sepsis Clinical Trial

— AMBIDEX  

Official title:

Ambisome® Preemptive Treatment of Multiple Colonizations by Candida in Intensive Care Patients With a Sepsis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00697944
• Other study ID #: AMBIDEX
• Secondary ID: EUDRA-CT 2007-00
• Status: Recruiting
• Phase: Phase 4
• First received: June 12, 2008
• Last updated: June 13, 2008
• Start date: March 2008
• Est. completion date: March 2009

Study information

• Verified date: March 2009
• Source: Fovea
• Contact: Jean-François RI DREYFUS, MD PhD
• Phone: 33-61-282-6780
• Email: jfdreyfus[@]aol.com
• Is FDA regulated: No
• Health authority: France: Institutional Ethical Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Candida
• Sepsis
• Toxemia

Intervention

Drug:
• Amphotericine in liposome (Ambisome®)
2 IV infusions separated by one week 10 mg/kg per injection

Locations

Country	Name	City	State
France	Chu Michallon	Grenoble
France	Hopital Saint Louis	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Fovea	Gilead Sciences

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global assessment of severity of adverse events; incidence, severity and consequences of treatment emergent effects		28-day observation period	Yes
Secondary	Duration of stay in the intensive care unit; occurrence of a systemic fungal infection		28 days after first treatment administration	No