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Sponsored by: |
Assistance Publique - Hôpitaux de Paris |
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Information provided by: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT00467883 |
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.
Condition | Intervention | Phase |
---|---|---|
Zygomycosis |
Drug: Liposomal Amphotericin B |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | AMBIZYGO: Efficacy of High Dose [10 mg/kg/j] Liposomal Amphotericin B (Ambisome)Efficacy in Initial Zygomycosis Treatment:Phase II Trial |
Estimated Enrollment: | 40 |
Study Start Date: | June 2007 |
Estimated Study Completion Date: | September 2010 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
amphotericin B: Experimental
Treatment with high dosage of amphotericin B liposomal 10 mg/kg/day during 4 weeks
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Drug: Liposomal Amphotericin B
high dosage
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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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Olivier Lortholary, MD, PhD | 0033144492663 | olivier.lortholary@nck.aphp.fr |
Contact: Raphaël Serreau, MD, PhD | 0033158411180 | raphael.serreau@cch.aphp.fr |
France | |
Hôpital Necker - Service des Maladies Infectieuses et Tropicales | Recruiting |
Paris, France, 75015 | |
Contact: Fanny Lanternier, MD 0033144492663 fanny.lanternier@nck.aphp.fr | |
Principal Investigator: Olivier Lortholary, MD, PhD | |
Necker Hospital | Recruiting |
Paris, France, 75015 | |
Principal Investigator: Lanternier Fanny, MD |
Principal Investigator: | Olivier Lortholary, MD, PhD | Assistance Publique - Hôpitaux de Paris |
Responsible Party: | Department Clinical Research of Developpement ( Dr Valérie Millul ) |
Study ID Numbers: | P060603 |
Study First Received: | April 30, 2007 |
Last Updated: | April 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00467883 History of Changes |
Health Authority: | France: Ministry of Health |
Zygomycosis High dose liposomal amphotericin B |
Abelcet Anti-Bacterial Agents Amphotericin B Mycoses Clotrimazole |
Miconazole Antifungal Agents Tioconazole Liposomal amphotericin B Zygomycosis |
Abelcet Amphotericin B Anti-Infective Agents Antiprotozoal Agents Liposomal amphotericin B Zygomycosis Pharmacologic Actions |
Mycoses Anti-Bacterial Agents Antiparasitic Agents Therapeutic Uses Antifungal Agents Antibiotics, Antifungal Amebicides |