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

Primary Purpose

Invasive Fungal Infection

Status

Completed

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

Micafungin

About this trial

This is an interventional treatment trial for Invasive Fungal Infection focused on measuring Adult, allo-Stem Cell Transplantation, Cord Blood

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

CHU de Nantes

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Micafungine

Arm Description

Outcomes

Primary Outcome Measures

Safety

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

Incidence of Invasive Fungal Infection

Incidence of Invasive Fungal Infection (IFI) at the end of prophylaxis period and at the end of the 4-week follow-up period

Incidence of fever of unknown origin

Incidence of fever of unknown origin requiring empirical antifungal treatment during prophylaxis period

Survival rate

Survival rate and incidence of mortality related to IFI from the start of prophylaxis until the end of the 4-week follow-up period.

Full Information

NCT ID

NCT01888458

First Posted

June 25, 2013

Last Updated

May 19, 2016

Sponsor

Nantes University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01888458

Brief Title

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

Acronym

MycaCOORD

Official Title

Antifungal Prophylaxis With Micafungin After Cord Blood Allogeneic Stem Cell Transplantation

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Completed

Study Start Date

September 2013 (undefined)

Primary Completion Date

April 2016 (Actual)

Study Completion Date

April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Nantes University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Invasive Fungal Infection

Keywords

Adult, allo-Stem Cell Transplantation, Cord Blood

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Micafungine

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Micafungin

Intervention Description

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 Measure Information:

Title

Safety

Description

Time Frame

50 days

Secondary Outcome Measure Information:

Title

Incidence of Invasive Fungal Infection

Description

Incidence of Invasive Fungal Infection (IFI) at the end of prophylaxis period and at the end of the 4-week follow-up period

Time Frame

50 days

Title

Incidence of fever of unknown origin

Description

Incidence of fever of unknown origin requiring empirical antifungal treatment during prophylaxis period

Time Frame

50 days

Title

Survival rate

Description

Survival rate and incidence of mortality related to IFI from the start of prophylaxis until the end of the 4-week follow-up period.

Time Frame

50 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Overall Study Officials: