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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
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
CHU de Nantes
Nantes, France
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.
Time frame: 50 days
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
Time frame: 50 days
Incidence of fever of unknown origin
Incidence of fever of unknown origin requiring empirical antifungal treatment during prophylaxis period
Time frame: 50 days
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.
Time frame: 50 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.