Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06541067

Study of Posaconazole Prophylaxis in Patients Receiving Hematopoietic Stem Cell Allograft (Allo-HSC) at High Risk of Invasive Fungal Infection (IFI)

Led by Nantes University Hospital · Updated on 2026-01-26

30

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Patients receiving an allogeneic hematopoietic stem cell transplant (allo-CSH) are at high risk of infection, particularly of fungal origin. Until the 2018 recommendations of the 6th European Conference on Infections in Leukemia (ECIL6), primary prophylaxis of invasive fungal infections (IFI), in allograft patients, was based on the administration of fluconazole until D100. Due to changes in transplantation practices (alternative donor transplantation, sequential transplantation, etc.) and changes in microbiological ecology (increased incidence of IFIs caused by filamentous germs such as aspergillosis and mycormycosis), fluconazole prophylaxis is now sometimes suboptimal. It is therefore recommended that patients at high risk of developing IFIs should be given azole molecules with activity against filamentous agents as primary prophylaxis during the first 3 months after transplantation. Posaconazole is often under-dosed (below the minimum effective concentration). It therefore seems essential to carry out a prospective study with close \[C\]min dosing in the specific situation of allograft patients, a population that appears to be at risk of underdosing in the light of initial retrospective analysis results.

CONDITIONS

Official Title

Study of Posaconazole Prophylaxis in Patients Receiving Hematopoietic Stem Cell Allograft (Allo-HSC) at High Risk of Invasive Fungal Infection (IFI)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient 18 years of age or older with no maximum age limit
  • Receiving allo-CSH transplant for hematologic malignancy or benign blood disorder with high risk of invasive fungal infection
  • High risk criteria include alternative donor, sequential conditioning, use of post-transplant cyclophosphamide, or previous HSC allograft
  • Signed informed consent before starting the study
  • Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
  • Women of childbearing age with negative pregnancy test and using effective contraception during treatment and for 12 months after stopping posaconazole
  • Men of childbearing age using effective contraception during treatment and for 6 months after stopping posaconazole
  • Negative tests for hepatitis B, C, and HIV
  • Affiliated with social security
Not Eligible

You will not qualify if you...

  • History of invasive fungal infection, active or resolved, at time of transplant
  • Known intolerance to posaconazole
  • Taking medications that cannot be combined with posaconazole, such as ergot alkaloids, certain CYP3A4 substrates, or specific statins
  • Congenital or acquired QTc prolongation with QTc over 470 ms
  • Reduced heart function with ejection fraction below 50%
  • Lung function with DLCOc less than 40% of expected
  • Kidney function with creatinine clearance below 50 ml/min
  • Liver tests showing transaminases more than 5 times normal or bilirubin more than 2 times normal
  • Pregnant or breastfeeding women
  • Women or men of childbearing age not using effective contraception
  • Serious uncontrolled infections
  • Yellow fever vaccination within the past year
  • Under legal protection such as guardianship or curatorship
  • Psychological, social, family, or geographic issues that may interfere with study compliance
  • Inability to speak or understand French
  • Participation in another therapeutic study with overlapping exclusion periods or planned simultaneous participation while on posaconazole

AI-Screening

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Trial Site Locations

Total: 1 location

1

CHU Nantes

Nantes, France, France, 44000

Actively Recruiting

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Research Team

A

Amandine LE BOURGEOIS, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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