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Phase II Trial of High Dose Liposomal Amphotericin B Efficacy in Initial Zygomycosis Treatment (AMBIZYGO)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00467883
First received: April 30, 2007
Last updated: July 30, 2012
Last verified: July 2012
History of Changes
  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 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: AMBIZYGO: Efficacy of High Dose [10 mg/kg/j] Liposomal Amphotericin B (Ambisome)Efficacy in Initial Zygomycosis Treatment:Phase II Trial

Resource links provided by NLM:

U.S. FDA Resources

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 ]

Enrollment: 40
Study Start Date: June 2007
Estimated Study Completion Date: December 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: amphotericin B
Treatment with high dosage of amphotericin B liposomal 10 mg/kg/day during 4 weeks
 Drug: Liposomal Amphotericin B
high dosage
Other Name: 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

Locations
France
Hôpital Necker - Service des Maladies Infectieuses et Tropicales
Paris, France, 75015
Necker Hospital
Paris, France, 75015
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: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00467883     History of Changes
Other Study ID Numbers: P060603
Study First Received: April 30, 2007
Last Updated: July 30, 2012
Health Authority: France: Ministry of Health

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

Additional relevant MeSH terms:
Zygomycosis
Mucormycosis
Mycoses
Amphotericin B
Liposomal amphotericin B
Amebicides
Antiprotozoal Agents
 Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on June 18, 2013