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

Zygomycosis Clinical Trial

— AMBIZYGO  

Official title:

AMBIZYGO: Efficacy of High Dose [10 mg/kg/j] Liposomal Amphotericin B (Ambisome)Efficacy in Initial Zygomycosis Treatment:Phase II Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00467883
• Other study ID #: P060603
• Status: Completed
• Phase: Phase 2
• First received: April 30, 2007
• Last updated: July 17, 2014
• Start date: June 2007
• Est. completion date: March 2013

Study information

• Verified date: July 2014
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2013
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mucormycosis
• Zygomycosis

Intervention

Drug:
• Liposomal Amphotericin B
high dosage

Locations

Country	Name	City	State
France	Hôpital Necker - Service des Maladies Infectieuses et Tropicales	Paris
France	Necker Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Efficacy, tolerance and survival after 15 days of treatment, cumulative dose of AmBisome® necessary to obtain objective response.		12 weeks	Yes