Status:
COMPLETED
Pilot Study of High Dose Liposomal Amphotericin B Efficacy in Initial Zygomycosis Treatment
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Zygomycosis
Eligibility:
All Genders
Phase:
PHASE2
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 tr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00467883
Start Date
June 1 2007
End Date
March 1 2013
Last Update
July 18 2014
Active Locations (2)
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1
Hôpital Necker - Service des Maladies Infectieuses et Tropicales
Paris, France, 75015
2
Necker Hospital
Paris, France, 75015