Ambisome® Preemptive Treatment of Multiple Candida Colonization in Sepsis Patients - Full Text View

Sponsors and Collaborators:	Fovea Gilead Sciences
Information provided by:	Fovea
ClinicalTrials.gov Identifier:	NCT00697944

Purpose

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

Condition	Intervention	Phase
Sepsis Candida	Drug: Amphotericine in liposome (Ambisome®)	Phase IV

MedlinePlus related topics: Fungal Infections Molds Sepsis

Drug Information available for: Amphotericin B

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Ambisome® Preemptive Treatment of Multiple Colonizations by Candida in Intensive Care Patients With a Sepsis

Further study details as provided by Fovea:

Primary Outcome Measures:

Global assessment of severity of adverse events; incidence, severity and consequences of treatment emergent effects [ Time Frame: 28−day observation period ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Duration of stay in the intensive care unit; occurrence of a systemic fungal infection [ Time Frame: 28 days after first treatment administration ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	March 2008
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Intervention Details:

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00697944

Contacts

Contact: Jean−François RI DREYFUS, MD PhD

33-61-282-6780

jfdreyfus@aol.com

Locations

France
Hopital Saint Louis	Not yet recruiting
PARIS, France, 75010
Chu Michallon	Recruiting
GRENOBLE, France, 38000
Contact: TIMSIT jftimsit@chu-grenoble.fr

Sponsors and Collaborators

Fovea

Gilead Sciences

Investigators

Principal Investigator:

Elie AZOULAY, MD PhD

University Teaching Hospital Saint Louis, Paris

More Information

Responsible Party:	FOVEA ( DREYFUS Medical director )
Study ID Numbers:	AMBIDEX, EUDRA−CT 2007−004444−71
Study First Received:	June 12, 2008
Last Updated:	June 13, 2008
ClinicalTrials.gov Identifier:	NCT00697944
Health Authority:	France: Institutional Ethical Committee

Keywords provided by Fovea:

FUNGAL INFECTION
SEPSIS
INTENSIVE CARE

AMBISOME
PREEMPTIVE TREATMENT
Sepsis with candida colonisation

Study placed in the following topic categories:

Abelcet
Systemic Inflammatory Response Syndrome
Amphotericin B
Mycoses
Sepsis
Clotrimazole

Miconazole
Tioconazole
Liposomal amphotericin B
Torulopsis
Inflammation

Additional relevant MeSH terms:

Anti-Bacterial Agents
Anti-Infective Agents
Antiparasitic Agents
Antiprotozoal Agents
Pathologic Processes
Antifungal Agents

Therapeutic Uses
Antibiotics, Antifungal
Amebicides
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009