- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01888458
Antifungal Prophylaxis With Micafungin After Cord Blood Allogeneic Stem Cell Transplantation (MycaCOORD) (MycaCOORD)
Antifungal Prophylaxis With Micafungin After Cord Blood Allogeneic Stem Cell Transplantation
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.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
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Nantes, France, 44093
- CHU de Nantes
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Micafungine
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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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
50 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
50 days
|
Incidence of fever of unknown origin
Time Frame: 50 days
|
Incidence of fever of unknown origin requiring empirical antifungal treatment during prophylaxis period
|
50 days
|
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.
|
50 days
|
Collaborators and Investigators
Sponsor
Investigators
- 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
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC13_0008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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