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

Fovea

Status and phase: Unknown; Phase 4

Conditions: Candida; Sepsis

Treatments: Drug: Amphotericine in liposome (Ambisome®)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00697944

EUDRA-CT 2007-004444-71

AMBIDEX

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)