Individualised Dose Optimisation of Ganciclovir in Immunocompromised Children Trial (ID-MAGIC)

Summary

This study is being conducted at seven major children's hospitals in Australia and New Zealand to test a new approach for treating a virus, called cytomegalovirus in children with weakened immune systems. The researchers want to find out if using a web app to customise the dose of a medication called ganciclovir is better at clearing the virus over a six-week period compared to the standard method of giving the medication.

Timeline

Start

2024-10-29

Primary completion

2028-06

Completion

2028-12

Publications

• Background Heston SM, Young RR, Tanaka JS, Jenkins K, Vinesett R, Saccoccio FM, Martin PL, Chao NJ, Kelly MS. Risk Factors for CMV Viremia and Treatment-Associated Adverse Events Among Pediatric Hematopoietic Stem Cell Transplant Recipients. Open Forum Infect Dis. 2021 Dec 16;9(2):ofab639. doi: 10.1093/ofid/ofab639. eCollection 2022 Feb.
• Background Chan S, Godsell J, Horton M, Farchione A, Howson LJ, Margetts M, Jin C, Chatelier J, Yong M, Sasadeusz J, Douglass JA, Slade CA, Bryant VL. Case Report: Cytomegalovirus Disease Is an Under-Recognized Contributor to Morbidity and Mortality in Common Variable Immunodeficiency. Front Immunol. 2022 Feb 15;13:815193. doi: 10.3389/fimmu.2022.815193. eCollection 2022.
• Background El Haddad L, Ghantoji SS, Park AK, Batista MV, Schelfhout J, Hachem J, Lobo Y, Jiang Y, Rondon G, Champlin R, Chemaly RF. Clinical and economic burden of pre-emptive therapy of cytomegalovirus infection in hospitalized allogeneic hematopoietic cell transplant recipients. J Med Virol. 2020 Jan;92(1):86-95. doi: 10.1002/jmv.25574. Epub 2019 Sep 3.
• Background Singh N, Winston DJ, Razonable RR, Lyon GM, Silveira FP, Wagener MM, Limaye AP. Cost-effectiveness of Preemptive Therapy Versus Prophylaxis in a Randomized Clinical Trial for the Prevention of Cytomegalovirus Disease in Seronegative Liver Transplant Recipients With Seropositive Donors. Clin Infect Dis. 2021 Nov 2;73(9):e2739-e2745. doi: 10.1093/cid/ciaa1051.
• Background Tan SK, Waggoner JJ, Pinsky BA. Cytomegalovirus load at treatment initiation is predictive of time to resolution of viremia and duration of therapy in hematopoietic cell transplant recipients. J Clin Virol. 2015 Aug;69:179-83. doi: 10.1016/j.jcv.2015.06.006. Epub 2015 Jun 10.
• Background Rastogi S, Ricci A, Jin Z, Bhatia M, George D, Garvin JH, Hall M, Satwani P. Clinical and Economic Impact of Cytomegalovirus Infection among Children Undergoing Allogeneic Hematopoietic Cell Transplantation. Biol Blood Marrow Transplant. 2019 Jun;25(6):1253-1259. doi: 10.1016/j.bbmt.2018.11.028. Epub 2018 Nov 29.
• Background Camargo JF, Kimble E, Rosa R, Shimose LA, Bueno MX, Jeyakumar N, Morris MI, Abbo LM, Simkins J, Alencar MC, Benjamin C, Wieder E, Jimenez A, Beitinjaneh A, Goodman M, Byrnes JJ, Lekakis LJ, Pereira D, Komanduri KV. Impact of Cytomegalovirus Viral Load on Probability of Spontaneous Clearance and Response to Preemptive Therapy in Allogeneic Stem Cell Transplantation Recipients. Biol Blood Marrow Transplant. 2018 Apr;24(4):806-814. doi: 10.1016/j.bbmt.2017.11.038. Epub 2017 Dec 5.
• Background Acquier M, Taton B, Alain S, Garrigue I, Mary J, Pfirmann P, Visentin J, Hantz S, Merville P, Kaminski H, Couzi L. Cytomegalovirus DNAemia Requiring (Val)Ganciclovir Treatment for More Than 8 Weeks Is a Key Factor in the Development of Antiviral Drug Resistance. Open Forum Infect Dis. 2023 Jan 23;10(2):ofad018. doi: 10.1093/ofid/ofad018. eCollection 2023 Feb.
• Background Jang JE, Hyun SY, Kim YD, Yoon SH, Hwang DY, Kim SJ, Kim Y, Kim JS, Cheong JW, Min YH. Risk factors for progression from cytomegalovirus viremia to cytomegalovirus disease after allogeneic hematopoietic stem cell transplantation. Biol Blood Marrow Transplant. 2012 Jun;18(6):881-6. doi: 10.1016/j.bbmt.2011.10.037. Epub 2011 Nov 4.
• Background Launay E, Theoret Y, Litalien C, Duval M, Alvarez F, Lapeyraque AL, Phan V, Larocque D, Poirier N, Lamarre V, Ovetchkine P. Pharmacokinetic profile of valganciclovir in pediatric transplant recipients. Pediatr Infect Dis J. 2012 Apr;31(4):405-7. doi: 10.1097/INF.0b013e3182463a19.
• Background Martson AG, Edwina AE, Kim HY, Knoester M, Touw DJ, Sturkenboom MGG, Alffenaar JC. Therapeutic Drug Monitoring of Ganciclovir: Where Are We? Ther Drug Monit. 2022 Feb 1;44(1):138-147. doi: 10.1097/FTD.0000000000000925.
• Background Franck B, Woillard JB, Theoret Y, Bittencourt H, Demers E, Briand A, Marquet P, Lapeyraque AL, Ovetchkine P, Autmizguine J. Population pharmacokinetics of ganciclovir and valganciclovir in paediatric solid organ and stem cell transplant recipients. Br J Clin Pharmacol. 2021 Aug;87(8):3105-3114. doi: 10.1111/bcp.14719. Epub 2021 Jan 19.
• Background Moretti S, Zikos P, Van Lint MT, Tedone E, Occhini D, Gualandi F, Lamparelli T, Mordini N, Berisso G, Bregante S, Bruno B, Bacigalupo A. Forscarnet vs ganciclovir for cytomegalovirus (CMV) antigenemia after allogeneic hemopoietic stem cell transplantation (HSCT): a randomised study. Bone Marrow Transplant. 1998 Jul;22(2):175-80. doi: 10.1038/sj.bmt.1701302.
• Background Al Yazidi LS, Mitchell R, Palasanthiran P, O'Brien TA, McMullan B. Management and prevention of cytomegalovirus infection in paediatric hematopoietic stem cell transplant (HSCT) recipients: A binational survey. Pediatr Transplant. 2019 Aug;23(5):e13458. doi: 10.1111/petr.13458. Epub 2019 May 12.
• Background Jorga K, Reigner B, Chavanne C, Alvaro G, Frey N. Pediatric Dosing of Ganciclovir and Valganciclovir: How Model-Based Simulations Can Prevent Underexposure and Potential Treatment Failure. CPT Pharmacometrics Syst Pharmacol. 2019 Mar;8(3):167-176. doi: 10.1002/psp4.12363. Epub 2018 Dec 18.
• Background Yong MK, Shigle TL, Kim YJ, Carpenter PA, Chemaly RF, Papanicolaou GA. American Society for Transplantation and Cellular Therapy Series: #4 - Cytomegalovirus treatment and management of resistant or refractory infections after hematopoietic cell transplantation. Transplant Cell Ther. 2021 Dec;27(12):957-967. doi: 10.1016/j.jtct.2021.09.010. Epub 2021 Sep 21.
• Background Xia W, Li HCW, Lam KWK, Chung OKJ, Song P, Chiu SY, Chan CG, Ho KY. The Impact of Hematologic Cancer and Its Treatment on Physical Activity Level and Quality of Life Among Children in Mainland China: A Descriptive Study. Cancer Nurs. 2019 Nov/Dec;42(6):492-500. doi: 10.1097/NCC.0000000000000661.
• Background Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts EA, Janecek E, Domecq C, Greenblatt DJ. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther. 1981 Aug;30(2):239-45. doi: 10.1038/clpt.1981.154. No abstract available.

Drugs

Indications