Ambisome® Preemptive Treatment of Multiple Candida Colonization in Sepsis Patients

NCT00697944 | Unknown Phase 4 DMC

• 2 other identifiers: AMBIDEXEUDRA-CT 2007-004444-71
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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

Conditions

Sepsis; Candida

Keywords

FUNGAL INFECTION; SEPSIS; INTENSIVE CARE; AMBISOME; PREEMPTIVE TREATMENT; Sepsis with candida colonisation

Outcome Measures

Primary Outcomes (1)

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

  28-day observation period

Secondary Outcomes (1)

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

  28 days after first treatment administration

Interventions

Amphotericine in liposome (Ambisome®) DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fovea: lead
• Gilead Sciences: collaborator

Study Sites (2)

Chu Michallon

Grenoble, 38000, France

RECRUITING

Hopital Saint Louis

Paris, 75010, France

NOT YET RECRUITING

Related Publications (1)

• Azoulay E, Timsit JF, Lautrette A, Legriel S, Max A, Ruckly S, Misset B, Cohen Y, Wolff M. Weekly high-dose liposomal amphotericin B (L-AmB) in critically ill septic patients with multiple Candida colonization: The AmBiDex study. PLoS One. 2017 May 22;12(5):e0177093. doi: 10.1371/journal.pone.0177093. eCollection 2017.

  PMID: 28531175 DERIVED

MeSH Terms

Conditions

Sepsis; Torulopsis; Mycoses

Interventions

Liposomes; liposomal amphotericin B

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

Membranes, Artificial; Biomedical and Dental Materials; Drug Carriers; Dosage Forms; Pharmaceutical Preparations; Manufactured Materials; Technology, Industry, and Agriculture; Biomimetic Materials

Study Officials

• Elie AZOULAY, MD PhD

  University Teaching Hospital Saint Louis, Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-François RI DREYFUS, MD PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 12, 2008
• First Posted: June 16, 2008
• Study Start: March 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: March 1, 2009
• Last Updated: June 16, 2008

Record last verified: 2009-03

Locations

FR (2)