Zygomycosis Clinical Trial
Official title:
AMBIZYGO: Efficacy of High Dose [10 mg/kg/j] Liposomal Amphotericin B (Ambisome)Efficacy in Initial Zygomycosis Treatment:Phase II Trial
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.
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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment