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

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Completed

CT.gov ID

NCT00467883

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Zygomycosis	Drug: Liposomal Amphotericin B	Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

AMBIZYGO: Efficacy of High Dose [10 mg/kg/j] Liposomal Amphotericin B (Ambisome)Efficacy in Initial Zygomycosis Treatment:Phase II Trial

Study Start Date :

Jun 1, 2007

Actual Primary Completion Date :

Jun 1, 2011

Actual Study Completion Date :

Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: amphotericin B Treatment with high dosage of amphotericin B liposomal 10 mg/kg/day during 4 weeks	Drug: Liposomal Amphotericin B high dosage Other Names: high dosage

Arm

Intervention/Treatment

Experimental: amphotericin B

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

Drug: Liposomal Amphotericin B

high dosage

Other Names:

high dosage

Outcome Measures

Primary Outcome Measures

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. [4 weeks]

Secondary Outcome Measures

Efficacy, tolerance and survival after 15 days of treatment, cumulative dose of AmBisome® necessary to obtain objective response. [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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