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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
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Scientific title
Invasive Fungal Infections in Patients Following Stem Cell Transplant
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Secondary ID [1]
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QA/64470/PMCC-2020
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Invasive Fungal Infections
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Stem Cell Transplant Complications
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Condition category
Condition code
Infection
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Studies of infection and infectious agents
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Infection
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Other infectious diseases
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Infection
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Sexually transmitted infections
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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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.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence of invasive fungal infections (IFI) in patients
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Assessment method [1]
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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.
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Timepoint [1]
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One year
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Secondary outcome [1]
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Breakthrough rates of invasive fungal infections (IFI)
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Assessment method [1]
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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.
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Timepoint [1]
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one year
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Secondary outcome [2]
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Mortality
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Assessment method [2]
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To determine all-cause mortality, non-relapse mortality and infection-related mortality in this cohort of patients.
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Timepoint [2]
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One year
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Secondary outcome [3]
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Current practice of antifungal prophylaxis
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Assessment method [3]
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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.
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Timepoint [3]
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one year
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Secondary outcome [4]
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Adverse effects from antifungal prescription
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Assessment method [4]
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Number of participants with adverse events from antifungal as assessed by CTCAE v5.0
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Timepoint [4]
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One year
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* None
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Study design
Purpose
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Duration
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Selection
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Timing
Retrospective
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Statistical methods / analysis
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Recruitment
Recruitment status
UNKNOWN
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
1/01/2021
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/03/2022
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Actual
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Sample size
Target
300
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment postcode(s) [1]
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3000 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Peter MacCallum Cancer Centre, Australia
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Address
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Country
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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Merck Sharp & Dohme LLC
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT04619147
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Trial related presentations / publications
Wingard JR. The changing face of invasive fungal infections in hematopoietic cell transplant recipients. Curr Opin Oncol. 2005 Mar;17(2):89-92. doi: 10.1097/01.cco.0000152975.65477.7c. Wingard JR, Hsu J, Hiemenz JW. Hematopoietic stem cell transplantation: an overview of infection risks and epidemiology. Infect Dis Clin North Am. 2010 Jun;24(2):257-72. doi: 10.1016/j.idc.2010.01.010. 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. Cornely OA, Gachot B, Akan H, Bassetti M, Uzun O, Kibbler C, Marchetti O, de Burghgraeve P, Ramadan S, Pylkkanen L, Ameye L, Paesmans M, Donnelly JP; EORTC Infectious Diseases Group. Epidemiology and outcome of fungemia in a cancer Cohort of the Infectious Diseases Group (IDG) of the European Organization for Research and Treatment of Cancer (EORTC 65031). Clin Infect Dis. 2015 Aug 1;61(3):324-31. doi: 10.1093/cid/civ293. Epub 2015 Apr 13. Erratum In: Clin Infect Dis. 2015 Nov 15;61(10):1635. doi: 10.1093/cid/civ820. Donnelly, Peter J [corrected to Donnelly, J Peter]. Clin Infect Dis. 2022 May 30;74(10):1892. doi: 10.1093/cid/ciac144. Marr KA, Carter RA, Boeckh M, Martin P, Corey L. Invasive aspergillosis in allogeneic stem cell transplant recipients: changes in epidemiology and risk factors. Blood. 2002 Dec 15;100(13):4358-66. doi: 10.1182/blood-2002-05-1496. Epub 2002 Aug 22. 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. Cornely OA, Maertens J, Winston DJ, Perfect J, Ullmann AJ, Walsh TJ, Helfgott D, Holowiecki J, Stockelberg D, Goh YT, Petrini M, Hardalo C, Suresh R, Angulo-Gonzalez D. Posaconazole vs. fluconazole or itraconazole prophylaxis in patients with neutropenia. N Engl J Med. 2007 Jan 25;356(4):348-59. doi: 10.1056/NEJMoa061094. Ethier MC, Science M, Beyene J, Briel M, Lehrnbecher T, Sung L. Mould-active compared with fluconazole prophylaxis to prevent invasive fungal diseases in cancer patients receiving chemotherapy or haematopoietic stem-cell transplantation: a systematic review and meta-analysis of randomised controlled trials. Br J Cancer. 2012 May 8;106(10):1626-37. doi: 10.1038/bjc.2012.147. Ananda-Rajah MR, Grigg A, Slavin MA. Making sense of posaconazole therapeutic drug monitoring: a practical approach. Curr Opin Infect Dis. 2012 Dec;25(6):605-11. doi: 10.1097/QCO.0b013e328359a56e. Fleming S, Yannakou CK, Haeusler GM, Clark J, Grigg A, Heath CH, Bajel A, van Hal SJ, Chen SC, Milliken ST, Morrissey CO, Tam CS, Szer J, Weinkove R, Slavin MA. Consensus guidelines for antifungal prophylaxis in haematological malignancy and haemopoietic stem cell transplantation, 2014. Intern Med J. 2014 Dec;44(12b):1283-97. doi: 10.1111/imj.12595. Dekkers BGJ, Bakker M, van der Elst KCM, Sturkenboom MGG, Veringa A, Span LFR, Alffenaar JC. Therapeutic Drug Monitoring of Posaconazole: an Update. Curr Fungal Infect Rep. 2016;10:51-61. doi: 10.1007/s12281-016-0255-4. Epub 2016 May 7. van Hal SJ, Gilroy NM, Morrissey CO, Worth LJ, Szer J, Tam CS, Chen SC, Thursky KA, Slavin MA. Survey of antifungal prophylaxis and fungal diagnostic tests employed in malignant haematology and haemopoietic stem cell transplantation (HSCT) in Australia and New Zealand. Intern Med J. 2014 Dec;44(12b):1277-82. doi: 10.1111/imj.12594. Cornely OA, Duarte RF, Haider S, Chandrasekar P, Helfgott D, Jimenez JL, Candoni A, Raad I, Laverdiere M, Langston A, Kartsonis N, Van Iersel M, Connelly N, Waskin H. Phase 3 pharmacokinetics and safety study of a posaconazole tablet formulation in patients at risk for invasive fungal disease. J Antimicrob Chemother. 2016 Mar;71(3):718-26. doi: 10.1093/jac/dkv380. Epub 2015 Nov 26. Erratum In: J Antimicrob Chemother. 2016 Jun;71(6):1747. doi: 10.1093/jac/dkw079. Winston DJ, Bartoni K, Territo MC, Schiller GJ. Efficacy, safety, and breakthrough infections associated with standard long-term posaconazole antifungal prophylaxis in allogeneic stem cell transplantation recipients. Biol Blood Marrow Transplant. 2011 Apr;17(4):507-15. doi: 10.1016/j.bbmt.2010.04.017. Epub 2010 May 9. Auberger J, Lass-Florl C, Aigner M, Clausen J, Gastl G, Nachbaur D. Invasive fungal breakthrough infections, fungal colonization and emergence of resistant strains in high-risk patients receiving antifungal prophylaxis with posaconazole: real-life data from a single-centre institutional retrospective observational study. J Antimicrob Chemother. 2012 Sep;67(9):2268-73. doi: 10.1093/jac/dks189. Epub 2012 May 30. Lerolle N, Raffoux E, Socie G, Touratier S, Sauvageon H, Porcher R, Bretagne S, Bergeron A, Azoulay E, Molina JM, Lafaurie M. Breakthrough invasive fungal disease in patients receiving posaconazole primary prophylaxis: a 4-year study. Clin Microbiol Infect. 2014 Nov;20(11):O952-9. doi: 10.1111/1469-0691.12688. Epub 2014 Jul 12. Lamoth F, Chung SJ, Damonti L, Alexander BD. Changing Epidemiology of Invasive Mold Infections in Patients Receiving Azole Prophylaxis. Clin Infect Dis. 2017 Jun 1;64(11):1619-1621. doi: 10.1093/cid/cix130. Erratum In: Clin Infect Dis. 2017 Oct 15;65(8):1431-1433. doi: 10.1093/cid/cix563. Kimura M, Araoka H, Yamamoto H, Asano-Mori Y, Nakamura S, Yamagoe S, Ohno H, Miyazaki Y, Abe M, Yuasa M, Kaji D, Kageyama K, Nishida A, Ishiwata K, Takagi S, Yamamoto G, Uchida N, Izutsu K, Wake A, Taniguchi S, Yoneyama A. Clinical and Microbiological Characteristics of Breakthrough Candidemia in Allogeneic Hematopoietic Stem Cell Transplant Recipients in a Japanese Hospital. Antimicrob Agents Chemother. 2017 Mar 24;61(4):e01791-16. doi: 10.1128/AAC.01791-16. Print 2017 Apr. Tverdek FP, Heo ST, Aitken SL, Granwehr B, Kontoyiannis DP. Real-Life Assessment of the Safety and Effectiveness of the New Tablet and Intravenous Formulations of Posaconazole in the Prophylaxis of Invasive Fungal Infections via Analysis of 343 Courses. Antimicrob Agents Chemother. 2017 Jul 25;61(8):e00188-17. doi: 10.1128/AAC.00188-17. Print 2017 Aug. Wood GM, McCormack JG, Muir DB, Ellis DH, Ridley MF, Pritchard R, Harrison M. Clinical features of human infection with Scedosporium inflatum. Clin Infect Dis. 1992 May;14(5):1027-33. doi: 10.1093/clinids/14.5.1027.
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Public notes
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Contacts
Principal investigator
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Address
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Megan Crane, PhD, MIDI
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Address
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Phone
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+613 85598016
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
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No/undecided IPD sharing reason/comment
De-identified demographics data of patients, transplant characteristic, details of invasive fungal infections
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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