Pilot Study of High Dose Liposomal Amphotericin B Efficacy in Initial Zygomycosis Treatment
AMBIZYGO
AMBIZYGO: Efficacy of High Dose [10 mg/kg/j] Liposomal Amphotericin B (Ambisome)Efficacy in Initial Zygomycosis Treatment:Phase II Trial
1 other identifier
interventional
40
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2007
Longer than P75 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2007
CompletedFirst Posted
Study publicly available on registry
May 1, 2007
CompletedStudy Start
First participant enrolled
June 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedMarch 4, 2026
February 1, 2026
4 years
April 30, 2007
March 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
4 weeks
Secondary Outcomes (1)
Efficacy, tolerance and survival after 15 days of treatment, cumulative dose of AmBisome® necessary to obtain objective response.
12 weeks
Study Arms (1)
amphotericin B
EXPERIMENTALTreatment with high dosage of amphotericin B liposomal 10 mg/kg/day during 4 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Life expectancy below 72 hours,
- Pregnancy, breast feeding,
- Polyene hypersensitivity,
- Absence of histologic or mycologic zygomycosis documentation,
- Absence of informed consent,
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Hôpital Necker - Service des Maladies Infectieuses et Tropicales
Paris, 75015, France
Necker Hospital
Paris, 75015, France
Related Publications (1)
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.
PMID: 26316385RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Olivier Lortholary, MD, PhD
Assistance Publique Hopitaux de Paris
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2007
First Posted
May 1, 2007
Study Start
June 1, 2007
Primary Completion
June 1, 2011
Study Completion
March 1, 2013
Last Updated
March 4, 2026
Record last verified: 2026-02