Ambisome® Preemptive Treatment of Multiple Candida Colonization in Sepsis Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2009-03-31

Brief Summary

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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

Detailed Description

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Conditions

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Sepsis Candida

Keywords

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Amphotericine in liposome (Ambisome®)

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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FOVEA

Principal Investigators

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Elie AZOULAY, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University Teaching Hospital Saint Louis, Paris

Locations

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Chu Michallon

Grenoble, , France

Site Status RECRUITING

Hopital Saint Louis

Paris, , France

Site Status NOT_YET_RECRUITING

Countries

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France

Central Contacts

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Jean-François RI DREYFUS, MD PhD

Role: CONTACT

Phone: 33-61-282-6780

Email: [email protected]

Facility Contacts

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TIMSIT

Role: primary

References

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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.

Reference Type DERIVED

PMID: 28531175 (View on PubMed)

Other Identifiers

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EUDRA-CT 2007-004444-71

Identifier Type: -

Identifier Source: secondary_id

AMBIDEX