Antifungal Prophylaxis With Micafungin After Cord Blood Allogeneic Stem Cell Transplantation (MycaCOORD) (MycaCOORD)
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|ClinicalTrials.gov Identifier: NCT01888458|
Recruitment Status : Completed
First Posted : June 27, 2013
Last Update Posted : May 20, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Invasive Fungal Infection||Drug: Micafungin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Antifungal Prophylaxis With Micafungin After Cord Blood Allogeneic Stem Cell Transplantation|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||April 2016|
|Actual Study Completion Date :||April 2016|
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
- 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.
- 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
- Incidence of fever of unknown origin [ Time Frame: 50 days ]Incidence of fever of unknown origin requiring empirical antifungal treatment during prophylaxis period
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01888458
|CHU de Nantes|
|Nantes, France, 44093|
|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|