Phase II Trial of High Dose Liposomal Amphotericin B Efficacy in Initial Zygomycosis Treatment
Information source: Assistance Publique - Hôpitaux de Paris
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Zygomycosis
Intervention: Liposomal Amphotericin B (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Assistance Publique - Hôpitaux de Paris Official(s) and/or principal investigator(s):
Olivier Lortholary, MD, PhD, Principal Investigator, Affiliation: Assistance Publique - Hôpitaux de Paris
Overall contact:
Olivier Lortholary, MD, PhD, Phone: 0033144492663, Email: olivier.lortholary@nck.aphp.fr
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.
Clinical Details
Official title: AMBIZYGO: Efficacy of High Dose [10 mg/kg/j] Liposomal Amphotericin B (Ambisome)Efficacy in Initial Zygomycosis Treatment:Phase II Trial
Study design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: 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 outcome: Efficacy, tolerance and survival after 15 days of treatment, cumulative dose of AmBisome® necessary to obtain objective 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 : Phase II prospective, multicentric, non comparative therapeutic trial. 18 patients
will initially be evaluated after 4 weeks of treatment. In case of favourable outcome for
at least 6 patients, 8 other patients will be included.
Inclusion duration: 24 months Follow-up: 6 months Study duration: 30 months
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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Olivier Lortholary, MD, PhD, Phone: 0033144492663, Email: olivier.lortholary@nck.aphp.fr
Hôpital Necker - Service des Maladies Infectieuses et Tropicales, Paris 75015, France; Recruiting
Fanny Lanternier, MD, Phone: 0033144492663, Email: fanny.lanternier@nck.aphp.fr
Olivier Lortholary, MD, PhD, Principal Investigator
Necker Hospital, Paris 75015, France; Recruiting
Lanternier Fanny, MD, Principal Investigator
Additional Information
Starting date: June 2007
Ending date: September 2010
Last updated: April 1, 2009
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