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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Fovea.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Gilead Sciences
Information provided by:
Fovea
ClinicalTrials.gov Identifier:
NCT00697944
First received: June 12, 2008
Last updated: June 13, 2008
Last verified: March 2009
History of Changes
  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 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Ambisome® Preemptive Treatment of Multiple Colonizations by Candida in Intensive Care Patients With a Sepsis

Resource links provided by NLM:

U.S. FDA Resources

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:
    Drug: Amphotericine in liposome (Ambisome®)
    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
Chu Michallon Recruiting
Grenoble, France, 38000
Contact: TIMSIT         jftimsit@chu-grenoble.fr    
Hopital Saint Louis Not yet recruiting
Paris, France, 75010
Sponsors and Collaborators
Fovea
Gilead Sciences
Investigators
Principal Investigator: Elie AZOULAY, MD PhD University Teaching Hospital Saint Louis, Paris
  More Information

No publications provided

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

Keywords provided by Fovea:
FUNGAL INFECTION
SEPSIS
INTENSIVE CARE
 AMBISOME
PREEMPTIVE TREATMENT
Sepsis with candida colonisation

Additional relevant MeSH terms:
Sepsis
Toxemia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Amphotericin B
Liposomal amphotericin B
 Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 16, 2013