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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04619147




Registration number
NCT04619147
Ethics application status
Date submitted
4/10/2020
Date registered
6/11/2020
Date last updated
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
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/01/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2022
Actual
Sample size
Target
300
Accrual to date
Final
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
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04619147
Trial related presentations / publications
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Grow WB, Moreb JS, Roque D, Manion K, Leather H, Reddy V, Khan SA, Finiewicz KJ, Nguyen H, Clancy CJ, Mehta PS, Wingard JR. Late onset of invasive aspergillus infection in bone marrow transplant patients at a university hospital. Bone Marrow Transplant. 2002 Jan;29(1):15-9. doi: 10.1038/sj.bmt.1703332.
Yong MK, Ananda-Rajah M, Cameron PU, Morrissey CO, Spencer A, Ritchie D, Cheng AC, Lewin SR, Slavin M. Cytomegalovirus Reactivation Is Associated with Increased Risk of Late-Onset Invasive Fungal Disease after Allogeneic Hematopoietic Stem Cell Transplantation: A Multicenter Study in the Current Era of Viral Load Monitoring. Biol Blood Marrow Transplant. 2017 Nov;23(11):1961-1967. doi: 10.1016/j.bbmt.2017.07.025. Epub 2017 Aug 7.
Girmenia C, Raiola AM, Piciocchi A, Algarotti A, Stanzani M, Cudillo L, Pecoraro C, Guidi S, Iori AP, Montante B, Chiusolo P, Lanino E, Carella AM, Zucchetti E, Bruno B, Irrera G, Patriarca F, Baronciani D, Musso M, Prete A, Risitano AM, Russo D, Mordini N, Pastore D, Vacca A, Onida F, Falcioni S, Pisapia G, Milone G, Vallisa D, Olivieri A, Bonini A, Castagnola E, Sica S, Majolino I, Bosi A, Busca A, Arcese W, Bandini G, Bacigalupo A, Rambaldi A, Locasciulli A. Incidence and outcome of invasive fungal diseases after allogeneic stem cell transplantation: a prospective study of the Gruppo Italiano Trapianto Midollo Osseo (GITMO). Biol Blood Marrow Transplant. 2014 Jun;20(6):872-80. doi: 10.1016/j.bbmt.2014.03.004. Epub 2014 Mar 14.
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Marr KA, Carter RA, Crippa F, Wald A, Corey L. Epidemiology and outcome of mould infections in hematopoietic stem cell transplant recipients. Clin Infect Dis. 2002 Apr 1;34(7):909-17. doi: 10.1086/339202. Epub 2002 Feb 26.
Rotstein C, Bow EJ, Laverdiere M, Ioannou S, Carr D, Moghaddam N. Randomized placebo-controlled trial of fluconazole prophylaxis for neutropenic cancer patients: benefit based on purpose and intensity of cytotoxic therapy. The Canadian Fluconazole Prophylaxis Study Group. Clin Infect Dis. 1999 Feb;28(2):331-40. doi: 10.1086/515128.
Wald A, Leisenring W, van Burik JA, Bowden RA. Epidemiology of Aspergillus infections in a large cohort of patients undergoing bone marrow transplantation. J Infect Dis. 1997 Jun;175(6):1459-66. doi: 10.1086/516480.
Ceesay MM, Sadique Z, Harris R, Ehrlich A, Adams EJ, Pagliuca A. Prospective evaluation of the cost of diagnosis and treatment of invasive fungal disease in a cohort of adult haematology patients in the UK. J Antimicrob Chemother. 2015 Apr;70(4):1175-81. doi: 10.1093/jac/dku506. Epub 2014 Dec 21.
Ananda-Rajah MR, Cheng A, Morrissey CO, Spelman T, Dooley M, Neville AM, Slavin M. Attributable hospital cost and antifungal treatment of invasive fungal diseases in high-risk hematology patients: an economic modeling approach. Antimicrob Agents Chemother. 2011 May;55(5):1953-60. doi: 10.1128/AAC.01423-10. Epub 2011 Feb 28.
Goodman JL, Winston DJ, Greenfield RA, Chandrasekar PH, Fox B, Kaizer H, Shadduck RK, Shea TC, Stiff P, Friedman DJ, et al. A controlled trial of fluconazole to prevent fungal infections in patients undergoing bone marrow transplantation. N Engl J Med. 1992 Mar 26;326(13):845-51. doi: 10.1056/NEJM199203263261301.
Slavin MA, Osborne B, Adams R, Levenstein MJ, Schoch HG, Feldman AR, Meyers JD, Bowden RA. Efficacy and safety of fluconazole prophylaxis for fungal infections after marrow transplantation--a prospective, randomized, double-blind study. J Infect Dis. 1995 Jun;171(6):1545-52. doi: 10.1093/infdis/171.6.1545.
Dykewicz CA; National Center for Infectious Diseases, Centers for Disease Control and Prevention; Infectious Diseases Society of America; American Society for Blood and Marrow Transplantation. Guidelines for preventing opportunistic infections among hematopoietic stem cell transplant recipients: focus on community respiratory virus infections. Biol Blood Marrow Transplant. 2001;7 Suppl:19S-22S. doi: 10.1053/bbmt.2001.v7.pm11777100.
Ullmann AJ, Lipton JH, Vesole DH, Chandrasekar P, Langston A, Tarantolo SR, Greinix H, Morais de Azevedo W, Reddy V, Boparai N, Pedicone L, Patino H, Durrant S. Posaconazole or fluconazole for prophylaxis in severe graft-versus-host disease. N Engl J Med. 2007 Jan 25;356(4):335-47. doi: 10.1056/NEJMoa061098. Erratum In: N Engl J Med. 2007 Jul 26;357(4):428.
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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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04619147