Pilot Study of High Dose Liposomal Amphotericin B Efficacy in Initial Zygomycosis Treatment (AMBIZYGO)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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|
- 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 ] [ Designated as safety issue: Yes ]
- Efficacy, tolerance and survival after 15 days of treatment, cumulative dose of AmBisome® necessary to obtain objective response. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2007|
|Study Completion Date:||March 2013|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
Experimental: amphotericin B
Treatment with high dosage of amphotericin B liposomal 10 mg/kg/day during 4 weeks
Drug: Liposomal Amphotericin B
Other Name: high dosage
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00467883
|Hôpital Necker - Service des Maladies Infectieuses et Tropicales|
|Paris, France, 75015|
|Paris, France, 75015|
|Principal Investigator:||Olivier Lortholary, MD, PhD||Assistance Publique - Hôpitaux de Paris|