Invasive Fungal Infections in Patients Following Stem Cell Transplant

NCT04619147 | Completed

• 1 other identifier: QA/64470/PMCC-2020
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Invasive Fungal Infections; Stem Cell Transplant Complications

Keywords

Posaconazole; Antifungal prophylaxis; Invasive fungal infections; Epidemiology; Allogeneic haematopoiectic stem cell transplant

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Breakthrough rates of invasive fungal infections (IFI)

  one year

• Mortality

  One year

• Current practice of antifungal prophylaxis

  one year

• Adverse effects from antifungal prescription

  One year

Study Arms (2)

Patients without invasive fungal infections (IFI)

This will be our control cohort. Most of the patients would have been on posaconazole prophylaxis.

Other: No intervention

Patients with invasive fungal infections (IFI)

This will be the group that we will be interested in. IFI would be diagnosed based on EORTC/ MSG definitions, and most of them would have been on posaconazole prophylaxis. Underlying risk factors of acquiring IFI in this cohort of patients will be compared with that of the control cohort.

Other: No intervention

Interventions

No intervention OTHER

This is descriptive, retrospective study to evaluate the epidemiology of invasive fungal infections (IFI) in patients undergoing allogeneic haematopoiectic stem cell transplant in the era of antifungal prophylaxis with posaconazole delay-released tablets.

Patients with invasive fungal infections (IFI); Patients without invasive fungal infections (IFI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Peter MacCallum Cancer Centre, Australia: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

Location

Related Publications (30)

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MeSH Terms

Conditions

Invasive Fungal Infections

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2020
• First Posted: November 6, 2020
• Study Start: January 15, 2022
• Primary Completion: April 20, 2024
• Study Completion: April 20, 2024
• Last Updated: November 14, 2024

Record last verified: 2024-11

Locations

AU (1)