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Pilot Study of High Dose Liposomal Amphotericin B Efficacy in Initial Zygomycosis Treatment

Study acronym: AMBIZYGO
StatusCompleted
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Amendment history

  1. Minor

    Collaborators expanded, about 5 words

    Publications: details revised at 1 of 1 entry

    Show what changed: Collaborators
    URC-CIC Paris Descartes Necker Cochin

    Study Status, Sponsor/Collaborators, Referencesv8

  2. Minor

    Study description shortened, about 39 words

    Study title shortened, about 1 word

    Show what changed: Study description
    [...] igh dose [10 mg/kg/j] or at maximal tolerable dose. Scheme : Phase II prospective, multicentric, non comparative therapeutic trialpilot study. 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 [...]
    Show what changed: Study title
    PhasePilot II TrialStudy of High Dose Liposomal Amphotericin B Efficacy in Initial Zygomycosis Treatment

    Study Identification, Study Status, Study Descriptionv7

  3. Minor

    Trial status: Active, Not Recruiting to Completed

    Study completion date changed from estimate of Dec 2012 to Mar 2013

    Study Statusv6

  4. Minor

    Completion date: Jun 2012 to Dec 2012

    Study Statusv5

  5. Minor

    Trial status: Recruiting to Active, Not Recruiting

    Primary completion date: Mar 2011 to Jun 2011; Completion date: Sep 2011 to Jun 2012; Site details revised at 2 of 2 sites

    Study Status, Sponsor/Collaborators, Study Design, Contacts/Locationsv4

Show 2 earlier versions

  1. Notable

    Primary completion date changed from estimate of Jul 2010 to Mar 2011

    Completion date: Sep 2010 to Sep 2011

    Study Status, Sponsor/Collaboratorsv3

  2. Notable

    Trial status: Not Yet Recruiting to Recruiting

    Enrollment target: 14 to 40; Study sites: 1 to 2; Primary completion date: Jul 2010; and 3 more

    Show all 7 changes in this update
    • Notable Trial status: Not Yet Recruiting to Recruiting
    • Notable Enrollment target: 14 to 40
    • Minor Study sites: 1 to 2
    • Minor Primary completion date: Jul 2010
    • Minor Completion date: May 2009 to Sep 2010
    • Minor Start date: May 2007 to Jun 2007
    • Minor Study arms: 0 to 1

    Study Status, Sponsor/Collaborators, Study Design, Arms and Interventions, Contacts/Locationsv2

  1. Minor

    Study First Submitted

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT00467883
Lead Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators: URC-CIC Paris Descartes Necker Cochin
Conditions Zygomycosis
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov