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

NCT ID: NCT01888458

Last Updated: 2016-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2016-04-30

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.

Conditions

Invasive Fungal Infection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Micafungine

Group Type: EXPERIMENTAL

Micafungin

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mauricette MICHALLET, PU PH

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Sabine FURST, PH

Role: PRINCIPAL_INVESTIGATOR

Institut Paoli et Calmette (Marseille)

Valérie COITEUX, PU PH

Role: PRINCIPAL_INVESTIGATOR

CHRU de Lille

Stéphane VIGOUROUX, PH

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Mohamad MOHTY, PU PH

Role: PRINCIPAL_INVESTIGATOR

AP-HP Saint Antoine

Thomas GASTINNE, PH

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

CHU de Nantes

Nantes, , France

Countries

France

Other Identifiers

RC13_0008

Identifier Type: -

Identifier Source: org_study_id