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

May 19, 2016 updated by: Nantes University Hospital

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

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Nantes, France, 44093
        • CHU de Nantes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

June 25, 2013

First Submitted That Met QC Criteria

June 26, 2013

First Posted (Estimate)

June 27, 2013

Study Record Updates

Last Update Posted (Estimate)

May 20, 2016

Last Update Submitted That Met QC Criteria

May 19, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

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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