Clinical Trial: Pilot Study of High Dose Liposomal Amphotericin B Efficacy in Initial Zygomycosis Treatment
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: AMBIZYGO: Efficacy of High Dose [10 mg/kg/j] Liposomal Amphotericin B (Ambisome)Efficacy in Initial Zygomycosis Treatment:Phase II Trial
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.
Detailed Summary:
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.
Sponsor: Assistance Publique - Hôpitaux de Paris
Current Primary Outcome: 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. [ Time Frame: 4 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Efficacy, tolerance and survival after 15 days of treatment, cumulative dose of AmBisome® necessary to obtain objective response. [ Time Frame: 12 weeks ]
Original Secondary Outcome: Same as current
Information By: Assistance Publique - Hôpitaux de Paris
Dates:
Date Received: April 30, 2007
Date Started: June 2007
Date Completion:
Last Updated: July 17, 2014
Last Verified: July 2014
