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Antifungal Prophylaxis With Micafungin After Cord Blood Allogeneic Stem Cell Transplantation (MycaCOORD) (MycaCOORD)

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ClinicalTrials.gov Identifier: NCT01888458
Recruitment Status : Completed
First Posted : June 27, 2013
Last Update Posted : May 20, 2016
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Brief Summary:

Infections due to post transplant immune deficiency are a major problem following allogeneic stem cell transplantation (Allo-SCT), particularly in patients receiving cord blood transplant (CB). Duration of neutropenia is one of the most important risk factor for invasive fungal infection (IFI). In this setting, Micafungin has been approved for antifungal prophylaxis for patients undergoing Allo-SCT. In a randomized, double-blind, comparative, phase III trial, the overall efficacy of micafungin was superior to that of fluconazole as antifungal prophylaxis during the neutropenic phase after Allo-SCT. However, very few patients in this study received a CB transplant.

This is phase IIb, prospective, open-label, non-comparative study to assess the safety of micafungin when use in prevention of IFI in neutropenic patients receiving allo-SCT using CB as source of stem cells.


Condition or disease Intervention/treatment Phase
Invasive Fungal Infection Drug: Micafungin Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Antifungal Prophylaxis With Micafungin After Cord Blood Allogeneic Stem Cell Transplantation
Study Start Date : September 2013
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Micafungine Drug: Micafungin
All patients meeting selection criteria will receive micafungin IV. Prophylaxis will start within 48 hours of the beginning of the transplant-related conditioning regimen until 5 days after recovery from neutropenia (ANC ≥ 500/µl), or occurrence of an IFI, or up to 42 days, or withdrawal for any reason (e.g. patient's or investigator's decision, development of intolerance, death), whichever come first




Primary Outcome Measures :
  1. Safety [ Time Frame: 50 days ]
    Safety assessed by the incidence and type of adverse events (AE) occurring during the course of prophylaxis treatment, AE related to study drug, AE leading to study drug discontinuation, and evolution of vital signs and biological parameters.


Secondary Outcome Measures :
  1. Incidence of Invasive Fungal Infection [ Time Frame: 50 days ]
    Incidence of Invasive Fungal Infection (IFI) at the end of prophylaxis period and at the end of the 4-week follow-up period

  2. Incidence of fever of unknown origin [ Time Frame: 50 days ]
    Incidence of fever of unknown origin requiring empirical antifungal treatment during prophylaxis period

  3. Survival rate [ Time Frame: 50 days ]
    Survival rate and incidence of mortality related to IFI from the start of prophylaxis until the end of the 4-week follow-up period.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients receiving allo-Stem Cell Transplantation using Cord Blood as source of stem cells (cf conditioning regimen recommendation).
  • Sex male or female
  • Age between 18 and 65 years at the time of signing the informed consent form.
  • Diagnosis of an hematologic disease for who a allograft decision has been taken
  • not having a (HLA)-matched related or unrelated donor within two month after complete remission achievement
  • Able to understand and voluntarily sign an informed consent form.
  • Subjects affiliated with an appropriate social security system
  • Male, female without childbearing potential or negative urine pregnancy test at the screening visit prior to beginning the treatment. Women of childbearing potential must be following adequate contraceptive measures. Men must agree to use an acceptable method of contraception (for themselves or female partners) for the duration of the study
  • Each subject will weigh 40 kg or more

Exclusion Criteria:

  • Any suspected or documented invasive fungal infection at study entry or at any time prior to study entry
  • Use of any systemic antifungal therapy within 72 hours prior to study entry
  • Known history of allergy, hypersensitivity or intolerance to echinocandin agents
  • Patient with any medical, psychological or social condition, which in the opinion of the investigator could increase the risk to the patient, or decrease the chance of obtaining satisfactory data to achieve the objectives of this study.
  • Participation in a study testing a new drug or a new conditioning
  • HIV, HBV or HCV positive
  • Pregnant or breast feeding females.
  • Subject protected by law.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01888458


Locations
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France
CHU de Nantes
Nantes, France, 44093
Sponsors and Collaborators
Nantes University Hospital
Investigators
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Principal Investigator: Mauricette MICHALLET, PU PH CHU de Lyon
Principal Investigator: Sabine FURST, PH Institut Paoli et Calmette (Marseille)
Principal Investigator: Valérie COITEUX, PU PH CHRU de Lille
Principal Investigator: Stéphane VIGOUROUX, PH University Hospital, Bordeaux
Principal Investigator: Mohamad MOHTY, PU PH AP-HP Saint Antoine
Principal Investigator: Thomas GASTINNE, PH CHU de Nantes

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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01888458     History of Changes
Other Study ID Numbers: RC13_0008
First Posted: June 27, 2013    Key Record Dates
Last Update Posted: May 20, 2016
Last Verified: May 2016

Keywords provided by Nantes University Hospital:
Adult
allo-Stem Cell Transplantation
Cord Blood

Additional relevant MeSH terms:
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Mycoses
Invasive Fungal Infections
Antifungal Agents
Miconazole
Micafungin
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP3A Inhibitors