Stem Cell Transplant Complications Clinical Trial
Official title:
Invasive Fungal Infections in Patients Following Stem Cell Transplant
This study will be a descriptive, retrospective evaluation and analysis of invasive fungal infections (IFI) conducted in patients who underwent allogeneic haematopoiectic stem cell transplant (aHSCT) in a single tertiary transplant centre, the Bone Marrow Transplant Clinical Service across Peter MacCallum Cancer Centre (PMCC) and Royal Melbourne Hospital (RMH), Victoria, Australia.
Status | Not yet recruiting |
Enrollment | 300 |
Est. completion date | March 2022 |
Est. primary completion date | January 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - All patients who are above 18 years of age, - Who underwent allogeneic haematopoietic stem cell transplant (aHSCT) from 1 January 2017 to 1 January 2019 with the Bone Marrow Transplant Clinical Service at Royal Melbourne Hospital (RMH) & Peter MacCallum Cancer Centre (PMCC), Victoria, Australia - Only the first transplant procedure will be included in the analysis Exclusion Criteria: - None |
Country | Name | City | State |
---|---|---|---|
Australia | Peter MacCallum Cancer Centre | Melbourne | Victoria |
Lead Sponsor | Collaborator |
---|---|
Peter MacCallum Cancer Centre, Australia | Merck Sharp & Dohme Corp. |
Australia,
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* Note: There are 30 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of invasive fungal infections (IFI) in patients | Incidence of IFI will be calculated as number of new episodes of IFI (index episode only) during the data collection period (1 Jan 2017 to 1 Jan 2019) over total number of patients who have undergone allogeneic stem cell transplant during the same period. | One year | |
Secondary | Breakthrough rates of invasive fungal infections (IFI) | Breakthrough IFI is defined as any IFI occurring during exposure to an antifungal drug, including fungi outside the spectrum of activity of an antifungal. Incidence of breakthrough rates of IFI will be calculated as number of episodes IFI over number of courses of anti fungal prophylaxis in a defined period. | one year | |
Secondary | Mortality | To determine all-cause mortality, non-relapse mortality and infection-related mortality in this cohort of patients. | One year | |
Secondary | Current practice of antifungal prophylaxis | Number of patients on different types of antifungal prophylaxis during a defined period. For patients who were on antifungal prophylaxis which required therapeutic drug monitoring (TDM)- proportion of patients who actually had TDM done and proportion of patients whose TDM was within therapeutic level. | one year | |
Secondary | Adverse effects from antifungal prescription | Number of participants with adverse events from antifungal as assessed by CTCAE v5.0 | One year |
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