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Phase II Trial of High Dose Liposomal Amphotericin B Efficacy in Initial Zygomycosis Treatment (AMBIZYGO)
This study is currently recruiting participants.
Verified by Assistance Publique - Hôpitaux de Paris, March 2009
First Received: April 30, 2007   Last Updated: April 1, 2009   History of Changes
Sponsored by: Assistance Publique - Hôpitaux de Paris
Information provided by: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00467883
  Purpose

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

Drug Information available for: Amphotericin B
U.S. FDA Resources
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

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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. [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Efficacy, tolerance and survival after 15 days of treatment, cumulative dose of AmBisome® necessary to obtain objective response. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

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
Drug: Liposomal Amphotericin B
high dosage

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00467883

Contacts
Contact: Olivier Lortholary, MD, PhD 0033144492663 olivier.lortholary@nck.aphp.fr
Contact: Raphaël Serreau, MD, PhD 0033158411180 raphael.serreau@cch.aphp.fr

Locations
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            
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Olivier Lortholary, MD, PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

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

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Zygomycosis
High dose liposomal amphotericin B

Study placed in the following topic categories:
Abelcet
Anti-Bacterial Agents
Amphotericin B
Mycoses
Clotrimazole
Miconazole
Antifungal Agents
Tioconazole
Liposomal amphotericin B
Zygomycosis

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009