Clinical trial NCT01888458: Antifungal Prophylaxis With Micafungin After Cord Blood Allogeneic Stem Cell Transplantation (MycaCOORD)
Official title: Antifungal Prophylaxis With Micafungin After Cord Blood Allogeneic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Invasive Fungal Infection
Keywords: Adult
allo-Stem Cell Transplantation
Cord Blood
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2013-06-27
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Safety
timeFrame: 50 days
Secondary outcomes:
measure: Incidence of Invasive Fungal Infection
timeFrame: 50 days
measure: Incidence of fever of unknown origin
timeFrame: 50 days
measure: Survival rate
timeFrame: 50 days
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU de Nantes
Study officials:
affiliation: Hospices Civils de Lyon
name: Mauricette MICHALLET, PU PH
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut Paoli et Calmette (Marseille)
name: Sabine FURST, PH
role: PRINCIPAL_INVESTIGATOR
affiliation: CHRU de Lille
name: Valérie COITEUX, PU PH
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Bordeaux
name: Stéphane VIGOUROUX, PH
role: PRINCIPAL_INVESTIGATOR
affiliation: AP-HP Saint Antoine
name: Mohamad MOHTY, PU PH
role: PRINCIPAL_INVESTIGATOR
affiliation: Nantes University Hospital
name: Thomas GASTINNE, PH
role: PRINCIPAL_INVESTIGATOR
References: