Clinical trial NCT00467883: Pilot Study of High Dose Liposomal Amphotericin B Efficacy in Initial Zygomycosis 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Zygomycosis
Keywords: Zygomycosis
High dose liposomal amphotericin B
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2007-05-01
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 \[10 mg/kg/j\] 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 4 weeks
Secondary outcomes:
measure: Efficacy, tolerance and survival after 15 days of treatment, cumulative dose of AmBisome® necessary to obtain objective response.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Necker - Service des Maladies Infectieuses et Tropicales
city: Paris
country: France
facility: Necker Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Olivier Lortholary, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lanternier F, Poiree S, Elie C, Garcia-Hermoso D, Bakouboula P, Sitbon K, Herbrecht R, Wolff M, Ribaud P, Lortholary O; French Mycosis Study Group. Prospective pilot study of high-dose (10 mg/kg/day) liposomal amphotericin B (L-AMB) for the initial treatment of mucormycosis. J Antimicrob Chemother. 2015 Nov;70(11):3116-23. doi: 10.1093/jac/dkv236. Epub 2015 Aug 27.