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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04619147




Registration number
NCT04619147
Ethics application status
Date submitted
4/10/2020
Date registered
6/11/2020

Titles & IDs
Public title
Invasive Fungal Infections in Patients Following Stem Cell Transplant
Scientific title
Invasive Fungal Infections in Patients Following Stem Cell Transplant
Secondary ID [1] 0 0
QA/64470/PMCC-2020
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Invasive Fungal Infections 0 0
Stem Cell Transplant Complications 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - No intervention

Patients without invasive fungal infections (IFI) - This will be our control cohort. Most of the patients would have been on posaconazole prophylaxis.

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 interventions: No intervention
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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of invasive fungal infections (IFI) in patients
Timepoint [1] 0 0
One year
Secondary outcome [1] 0 0
Breakthrough rates of invasive fungal infections (IFI)
Timepoint [1] 0 0
one year
Secondary outcome [2] 0 0
Mortality
Timepoint [2] 0 0
One year
Secondary outcome [3] 0 0
Current practice of antifungal prophylaxis
Timepoint [3] 0 0
one year
Secondary outcome [4] 0 0
Adverse effects from antifungal prescription
Timepoint [4] 0 0
One year

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* None

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/01/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/04/2024
Sample size
Target
Accrual to date
Final
300
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
3000 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Peter MacCallum Cancer Centre, Australia
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Merck Sharp & Dohme LLC
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Megan Crane, PhD, MIDI
Address 0 0
Country 0 0
Phone 0 0
+613 85598016
Fax 0 0
Email 0 0
Megan.Crane@petermac.org
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
De-identified demographics data of patients, transplant characteristic, details of invasive fungal infections


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04619147