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

Study acronym: POSALLO
StatusRecruiting
PhasePhase 2
Started2024-11-08
View on ClinicalTrials.gov ↗

Amendment history

2026-01-23
minor
Study Identification, Study Status, Oversight v2
Study titlerevised
Study of Posaconazole Prophylaxis in Patients Receiving Hematopoietic Stem Cell Allograft (alloAllo-HSC) Atat High Risk of Invasive Fungal Infection (IFI)
2025-01-28
notable
Not Yet Recruiting→Recruiting Study Identification, Study Status, Oversight, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Completion date2028-10-15→2028-11-08
Start dateestimated 2024-10-15→confirmed 2024-11-08
Study sitesdetails revised at 1 of 1 site
Study titlerevised
Study of Posaconazole Prophylaxis in Patients Receiving Hematopoietic Stem Cell Allograft (Alloallo-HSC) atAt High Risk of Invasive Fungal Infection (IFI)
2024-08-01
minor
Original filing
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.
Trial Details
NCT Number NCT06541067
Lead Sponsor Nantes University Hospital
Conditions Hematologic Malignancy
Enrollment 30 participants
Start Date 2024-11-08
Primary Completion 2027-01-15 (estimated)
Study Completion 2028-11-08 (estimated)
Updated on ClinicalTrials.gov 2026-01-26