Pilot Study of High Dose Liposomal Amphotericin B Efficacy in Initial Zygomycosis Treatment

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2013-03-31

Brief Summary

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Evaluation after 4 weeks of treatment or at end of treatment if it occurs before. Efficacy will be defined as objective responses; complete and partial response.

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Detailed Description

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Primary objective: Efficacy of 4 weeks of liposomal amphotericin B (AmBisome®) at high dose \[10 mg/kg/j\] or at maximal tolerable dose in initial zygomycosis treatment. Evaluation after 4 weeks of treatment or at end of treatment if it occurs before. Efficacy will be defined as objective responses; complete and partial response.

Secondary objectives: Efficacy, tolerance and survival after 15 days of treatment, cumulative dose of AmBisome® necessary to obtain objective response, efficacy in operated and non operated patients, tolerance after 4 and 12 weeks treatment, survival, and relapse rate at 6 months of 4 weeks of liposomal amphotericin B (AmBisome®) at high dose \[10 mg/kg/j\] or at maximal tolerable dose.

Scheme : prospective, multicentric, non comparative therapeutic pilot study.

Inclusion criteria: Presence on a tissue biopsy of large non septated hyphae compatible with zygomycete or presence of a zygomycete in culture associated with clinical or radiological abnormalities compatible with fungal invasive infection.

Exclusion criteria: Life expectancy below 72 hours, pregnancy, breast feeding, polyene hypersensitivity, absence of histologic or mycologic zygomycosis documentation, absence of informed consent, previous treatment with polyene or other antifungal active on zygomycete (posaconazole, itraconazole) over 5 days during the month previous inclusion.

Treatment : AmBisome® 10 mg/kg/j monotherapy during at least 15 days, then AmBisome® at maximal tolerable dose during 15 days associated with early optimal surgical treatment. After the first treatment month, following treatment is decided by referent physician.

Conditions

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Zygomycosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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amphotericin B

Treatment with high dosage of amphotericin B liposomal 10 mg/kg/day during 4 weeks

Group Type EXPERIMENTAL

Liposomal Amphotericin B

Intervention Type DRUG

high dosage

Interventions

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Liposomal Amphotericin B

high dosage

Intervention Type DRUG

Other Intervention Names

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high dosage

Eligibility Criteria

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Inclusion Criteria

* Presence on a tissue biopsy of large non septated hyphae compatible with zygomycete
* Presence of a zygomycete in culture associated with clinical or radiological abnormalities compatible with fungal invasive infection.

Exclusion Criteria

* Life expectancy below 72 hours,
* Pregnancy, breast feeding,
* Polyene hypersensitivity,
* Absence of histologic or mycologic zygomycosis documentation,
* Absence of informed consent,
* Previous treatment with polyene or other antifungal active on zygomycete (posaconazole, itraconazole) over 5 days during the month previous inclusion

Eligible Sex

ALL

Accepts Healthy Volunteers

No