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

NCT01888458 | Completed Phase 2 DMC

• 1 other identifier: RC13_0008
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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

Keywords

Adult; allo-Stem Cell Transplantation; Cord Blood

Outcome Measures

Primary Outcomes (1)

• 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.

  50 days

Secondary Outcomes (3)

• Incidence of Invasive Fungal Infection

  50 days

• Incidence of fever of unknown origin

  50 days

• Survival rate

  50 days

Study Arms (1)

Micafungine

EXPERIMENTAL

Drug: Micafungin

Interventions

Micafungin 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

Micafungine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

CHU de Nantes

Nantes, 44093, France

Location

MeSH Terms

Conditions

Invasive Fungal Infections

Interventions

Micafungin

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins; Echinocandins; Peptides, Cyclic

Study Officials

• Mauricette MICHALLET, PU PH

  Hospices Civils 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

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2013
• First Posted: June 27, 2013
• Study Start: September 1, 2013
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: May 20, 2016

Record last verified: 2016-05

Locations

FR (1)