Using Posaconazole to Prevent Fungal Infections in High-Risk Stem Cell Transplant Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the use of Posaconazole as a primary prophylactic treatment for patients receiving an allogeneic hematopoietic stem cell transplant (allo-CSH) who are at high risk for invasive fungal infections (IFI). The study aims to address the limitations of traditional fluconazole prophylaxis, which may be inadequate due to changes in transplantation practices and increased incidence of certain fungal infections. Participants will receive Posaconazole starting from the day of transplantation and continuing for three months, with monitoring for efficacy and safety. The trial seeks to establish the optimal dosing and effectiveness of Posaconazole in preventing IFIs in this vulnerable patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patient ≥ 18 years of age. There is no maximum age for inclusion
* Allo-CSH transplant for hematologic malignancy or benign hemopathy of any type with one or more high risk IFI criteria:

  * alternative donor (haploidentical intra-family donor, mismatch file donor, placental blood)
  * sequential conditioning for disease not in remission at the time of transplantation
  * use of post-transplant cyclophosphamide (PTCY) for GVH prophylaxis
  * patient who has previously received a HSC allograft
* Written informed consent prior to protocol initiation
* ECOG \<=2
* Female of childbearing age with negative pregnancy test and on highly effective contraception during treatment and for 12 months after posaconazole discontinuation
* Men of childbearing age with effective contraception during treatment and for 6 months after stopping posaconazole.
* Hepatitis B, C and HIV serologies negative.
* Social security affiliation

Exclusion Criteria:

* Patients with a history of IFI, whether active or resolved at the time of allografting
* Patient with known intolerance to posaconazole
* Patients with concomitant treatments FORBIDDING association with posaconazole: ergot alkaloids, CYP3A4 substrates (terfenadine, astemizole, cisapride, pimozide, halofantrine or quinidine), HMG-CoA reductase inhibitors (simvastatin, lovastatin and atorvastatin) or any other contraindicated treatment listed in VIDAL
* patients with congenital or acquired QTc prolongation (QTc \>470ms)
* Cardiac: systolic ejection fraction \< 50% by transthoracic ultrasound or isotopic method (isotopic gamma-angiography)
* Respiratory: DLCOc \<40% of theoretical on EFR
* Renal: creatinine clearance \< 50 ml/min (assessed using MDRD method)
* Hepatic: transaminases greater than 5 times normal or bilirubin greater than 2 times normal
* Pregnant or breast-feeding women,
* Women or men of childbearing age without effective contraception
* Serious, uncontrolled concomitant infections
* Yellow fever vaccination within the last year
* Patient protected by law (guardianship, curatorship, safeguard of justice)
* Psychological, family, sociological or geographical conditions that may hinder compliance with the study protocol and follow-up schedule
* Patient who does not speak or understand French
* Participation in any other therapeutic study with an exclusion period still in effect at the time of inclusion or planned participation in another therapeutic study while taking posaconazole

Where it's running

• CHU Nantes
  Nantes, France, France Recruiting

Study contacts

• Study coordinator: Amandine LE BOURGEOIS, MD
• Email: amandine.lebourgeois@chu-nantes.fr
• Phone: 02 40 08 32 71

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.