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

This study is not yet open for participant recruitment.
Verified by Assistance Publique - Hôpitaux de Paris, April 2007

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

ChemIDplus related topics:   Amphotericin B   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label, Uncontrolled, Single Group Assignment, 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 ]

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 ]

Estimated Enrollment:   14
Study Start Date:   May 2007
Estimated Study Completion Date:   May 2009

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     00144492663     olivier.lortholary@nck.aphp.fr    
Contact: Raphaël Serreau, MD     00144495969     raphael.serreau@nck.aphp.fr    

Locations
France
Hôpital Necker - Service des Maladies Infectieuses et Tropicales     Not yet recruiting
      Paris, France, 75015
      Contact: Fanny Lanternier, MD     0033144492663     fanny.lanternier@nck.aphp.fr    
      Principal Investigator: Olivier Lortholary, MD, PhD            

Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris

Investigators
Principal Investigator:     Olivier Lortholary, MD, PhD     Necker Hospital Assistance Publique Hôpitaux de Paris    
  More Information

Study ID Numbers:   P060603
First Received:   April 30, 2007
Last Updated:   April 30, 2007
ClinicalTrials.gov Identifier:   NCT00467883
Health Authority:   France: Afssaps - French Health Products Safety Agency

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

Study placed in the following topic categories:
Abelcet
Amphotericin B
Mycoses
Clotrimazole
Miconazole
AmBisome
Tioconazole
Zygomycosis

Additional relevant MeSH terms:
Anti-Bacterial Agents
Anti-Infective Agents
Antiparasitic Agents
Antiprotozoal Agents
Antifungal Agents
Therapeutic Uses
Antibiotics, Antifungal
Amebicides
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2008




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