Ignite Creation Date:
2024-05-05 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00467883
Status:
COMPLETED
Last Update Posted:
2014-07-18
First Post:
2007-04-30
Brief Title:
Pilot Study of High Dose Liposomal Amphotericin B Efficacy in Initial Zygomycosis Treatment
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
AMBIZYGO Efficacy of High Dose 10 mgkgj Liposomal Amphotericin B AmbisomeEfficacy in Initial Zygomycosis TreatmentPhase II Trial
Status:
COMPLETED
Status Verified Date:
2014-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AMBIZYGO
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 Description:
Primary objective Efficacy of 4 weeks of liposomal amphotericin B AmBisome at high dose 10 mgkgj 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 mgkgj 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 mgkgj 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
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 mgkgj 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 mgkgj 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None