Pilot Study of High Dose Liposomal Amphotericin B Efficacy in Initial Zygomycosis Treatment

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Amphotericin B; Liposomal amphotericin B

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