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

Phase 2

Completed

• Conditions: Zygomycosis
• Interventions: Drug: Liposomal Amphotericin B

• Registration Number: NCT00467883
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2007-04-30
• Study First Submitted QC: 2007-04-30
• Study First Posted: 2007-05-01
• Study Start: 2007-06
• Primary Completion: 2011-06
• Study Completion: 2013-03
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-17
• Last Update Posted: 2014-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
amphotericin B	Liposomal Amphotericin B	Treatment with high dosage of amphotericin B liposomal 10 mg/kg/day during 4 weeks

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Efficacy, tolerance and survival after 15 days of treatment, cumulative dose of AmBisome® necessary to obtain objective response.	12 weeks

Trial Locations

Locations (2)

Hôpital Necker - Service des Maladies Infectieuses et Tropicales; 🇫🇷 Paris, France

Necker Hospital; 🇫🇷 Paris, France