Cytomegalovirus ViraemiaPhase 2ID-MAGICNCT06574789
Individualised Dose Optimisation of Ganciclovir in Immunocompromised Children Trial (ID-MAGIC)
A Phase 2 study testing Standard dosing of IV ganciclovir and Personalised dosing of IV ganciclovir in people with Cytomegalovirus Viraemia, run by Murdoch Childrens Research Institute at 7 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Cytomegalovirus Viraemia
- What is being tested?
- Standard dosing of IV ganciclovir and Personalised dosing of IV ganciclovir
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 29 Oct 2024to Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Immunocompromised patients including transplant recipients (haematopoietic stem cell transplant (HSCT), solid organ transplant (SOT)), those receiving chemotherapy or other immunosuppression or those with a known/suspected inborn error of immunity (determined by an immunologist); and
- Detectable clinically significant CMV viraemia and treating clinician determines that antiviral therapy is indicated.
- Willing to partake in the trial
- Willing/able to attend all follow up visits and capable of completing all trial assessments.
- Legally acceptable parent/guardian capable of providing consent on the participant's behalf.
- Treating clinician agreeable to child being enrolled in the trial.
Who cannot join
- Current or prior CMV infection with documented genotypic resistance to GCV (UL97 and/or UL54); or
- Severe renal impairment (defined as estimated glomerular filtration rate (eGFR) <25mL/min); or
- Congenital CMV infection; or
- Life expectancy of less than 7 days as determined by the treating physician; or
- History of allergy, or adverse reaction to GCV, aciclovir or any component of the formulation; or
- Treating clinician determines that combination antiviral therapy is indicated for CMV infection; or
Show all 9Show fewer
- Has received >3 days of IV GCV or foscarnet or oral valganciclovir for the treatment of CMV infection prior to enrolment; or
- Prior enrolment in the trial; or
- Current recipient of another investigational product used for the treatment of CMV infection, as part of a clinical trial.
Trial locations and contacts
7 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 2 countries
Australia6 sites, 6 recruiting
- Recruiting
Queensland Children's Hospital
Brisbane, Queensland, 4101
Adam Irwin, a.irwin@uq.edu.au
- Recruiting
The Royal Children's Hospital
Melbourne, Victoria, 3052
Amanda Gwee, 03 9345 5522, amanda.gwee@rch.org.au
Amanda Gwee, MBBS
- Recruiting
Monash Children's Hospital
Melbourne, Victoria, 3168
Jeremy Carr, jeremy.carr@monashhealth.org
- Recruiting
Perth Children's Hospital
Perth, Western Australia, 6009
Daniel Yeoh, Daniel.Yeoh@health.wa.gov.au
- Recruiting
Sydney Children's Hospital
Sydney, New South Wales, 2031
Brendan McMullan, brendan.mcmullan@health.nsw.gov.au
- Recruiting
The Children's Hospital at Westmead
Sydney, New South Wales, 2145
Tony Lai, tony.lai@health.nsw.gov.au
New Zealand1 site, 1 recruiting
- Recruiting
Starship Children's Hospital
Auckland, North Island, 1023
Lesley Voss, lesleyv@adhb.govt.nz
Emma Best, ebest@adhb.govt.nz
About this study
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.
Read the detailed description
Immunocompromised children between 1 months to 18 years with cytomegalovirus viraemia who are admitted to one of the participating sites will be enrolled into the trial if eligible (see eligibility criteria) and randomly allocated into two groups. Children in the 'control- standard dosing group' will receive standard intravenous ganciclovir treatment for cytomegalovirus viraemia at a standard dosing of at 5mg/kg IV BD. Children in the "intervention: individualised dosing using a web app group" will receive a personalised intravenous ganciclovir dose calculated using an individualised IV ganciclovir dosing app. This approach considers the patient's weight, creatinine level, and target drug exposure, allowing for tailored dosing based on individual pharmacokinetic parameters. The virological clearance by 6 weeks of the children in each of the two groups will be compared.
- Conditions
- Cytomegalovirus Viraemia
- Being tested
- Standard dosing of IV ganciclovir, Personalised dosing of IV ganciclovir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard dosing of IV ganciclovirDrug
IV ganciclovir at standard dosing
Personalised dosing of IV ganciclovirDrug
IV ganciclovir at a personalised dosing calculated using a ganciclovir dosing web app
| Study group | Role | What they receive |
|---|---|---|
| Control: standard dosing | Active comparator | Enrolled participant will receive standard dosing of IV Ganciclovir dependent on renal function:
* CrCl >/= 70mL/min: 5 mg/kg IV 12 hourly
* CrCl >/= 50-69: 2.5 mg/kg/ IV 12 hourly
* CrCl >/= 25-49: 2.5 mg/kg IV 24 hourly Receives: Drug: Standard dosing of IV ganciclovir |
| Intervention: individualised dosing using a web app | Active comparator | Enrolled participant will receive a personalised dosing of IV Ganciclovir calculated using an individualised IV ganciclovir dosing app, that considers the patient's weight, creatinine level, and at a target drug exposure (AUC24 between 40-100 mg.h/L), allowing for tailored dosing based on individual pharmacokinetic parameters. Receives: Drug: Personalised dosing of IV ganciclovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of participants who achieve CMV virological clearance by 6 weeks
CMV virological clearance by 6 weeks to be compared between the two treatment groups. * Virological clearance defined as two consecutives negative CMV polymerase chain reaction results, or detectable but CMV viral load is less than the lower limit of detection. Separated by at least 72 hours by 6-weeks (42 days) after randomisation.
Measured: 42 days
Secondary outcomes (7)
The proportion of participants who achieve CMV virological clearance before 3-weeks
The proportion of children who achieve virological clearance before 3-weeks (21 days) to be compared between the two treatment arms. Virological clearance defined as two consecutives negative CMV polymerase chain reaction results, or detectable but CMV viral load is less than the lower limit of detection. Separated by at least 72 hours.
Measured: 21 days
The proportion of participants who develop CMV disease by 6 weeks
The proportion of children who develop CMV disease by 6 weeks to be compared between the two treatment groups. CMV disease assessed by the treating clinician based on signs/symptoms of disease followed by microbiological confirmation at the 6-week assessment.
Measured: 42 days
Difference between treatment groups in All-cause mortality by 6 months
All-cause mortality by 6 months to be compared between the two treatment groups. All-cause mortality assessed by chart ± telephone review by the research team at 6-month timepoint.
Measured: 6 months
The proportion of participants who develop drug resistant CMV infection by 6 months
The proportion of children who develop drug resistant CMV infection by 6 months to be compared between the two treatment groups. Children with refractory or further CMV infections following resolution of the initial infection will be evaluated for CMV-resistance through gene testing (UL97 and UL54).
Measured: 6 months
The proportion of participants with treatment-related adverse effects (AEs)
The proportion of children with any treatment-related AEs to be compared between the two treatment groups. Assessed at end of treatment or at 6 weeks (whichever is later) by the treating team.
Measured: 42 days
Change in Quality of Life measured over 6 months using the EQ-5D-Y Questionnaire.
Quality of Life (QoL) over the 6-month period following randomisation to be compared between the two treatment groups using the QoL EQ-5D-Y questionnaire, assessed at 7 days, 42 days and 180 days.
The EQ-5D-Y descriptive system comprises the following five dimensions: mobility, looking after oneself, doing usual activities, having pain or discomfort and feeling worried, sad or unhappy. Each dimension has 3 levels: no problems, some problems and a lot of problems.
The final question measures how good or bad the participants' health is that day on a scale from 0 to 100. 100 means the best health they can imagine and 0 means the worst health they can imagine.
Measured: 7 days, 42 days, 180 days
Difference between treatment groups in cost-effectiveness over the 6-month period following randomisation
The total sum of all hospital and patient/family resources required per patient over the 6-month period to be compared between the two treatment groups.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start29 Oct 2024
- Primary completionJun 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Cytomegalovirus ViraemiaStudies of the same condition, open and under way.
- More trials run by Murdoch Childrens Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 232 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Murdoch Childrens Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amanda Gwee, Principal investigator, Murdoch Childrens Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06574789
- Sponsor's protocol ID
- 107507
- Acronym
- ID-MAGIC
- Status last verified
- Sep 2025
- First submitted
- 20 Aug 2024
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Beginning 12 months following analysis and article publication, upon approval of the request, the following will be made available long-term for use by future researchers from a recognised research institution whose proposed use of the data has been ethically reviewed and approved by an independent committee and who accept MCRI's conditions for access: * Individual participant data that underlie the results reported in this article after deidentification (text, tables, figures, and appendices) * Trial protocol, Statistical Analysis Plan, PICF
Publications
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.
PubMed 35111869Chan 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.
PubMed 35242131El 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.
PubMed 31448830Singh 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.
PubMed 32712663Tan 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.
PubMed 26209403Rastogi 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.
PubMed 30502538Camargo 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.
PubMed 29217388Acquier 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.
PubMed 36817745Jang 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.
PubMed 22062802Launay 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.
PubMed 22198827Martson 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.
PubMed 34610621Franck 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.
PubMed 33373493Moretti 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.
PubMed 9707026Al 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.
PubMed 31081265Jorga 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.
PubMed 30354026
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualised Dose Optimisation of Ganciclovir in Immunocompromised Children Trial (ID-MAGIC)
- ClinicalTrials.gov ID
- NCT06574789
- Acronym / sponsor ID
- ID-MAGIC / 107507
- Conditions
- Cytomegalovirus Viraemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 232 participants (estimated)
- Lead sponsor
- Murdoch Childrens Research InstituteUniversity, hospital or other
- Study start
- 29 Oct 2024 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 28 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Immunocompromised children between 1 months to 18 years with cytomegalovirus viraemia who are admitted to one of the participating sites will be enrolled into the trial if eligible (see eligibility criteria) and randomly allocated into two groups. Children in the 'control- standard dosing group' will receive standard intravenous ganciclovir treatment for cytomegalovirus viraemia at a standard dosing of at 5mg/kg IV BD. Children in the "intervention: individualised dosing using a web app group" will receive a personalised intravenous ganciclovir dose calculated using an individualised IV ganciclovir dosing app. This approach considers the patient's weight, creatinine level, and target drug exposure, allowing for tailored dosing based on individual pharmacokinetic parameters. The virological clearance by 6 weeks of the children in each of the two groups will be compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control: standard dosing | Active comparator | Drug: Standard dosing of IV ganciclovirEnrolled participant will receive standard dosing of IV Ganciclovir dependent on renal function: * CrCl >/= 70mL/min: 5 mg/kg IV 12 hourly * CrCl >/= 50-69: 2.5 mg/kg/ IV 12 hourly * CrCl >/= 25-49: 2.5 mg/kg IV 24 hourly |
| Intervention: individualised dosing using a web app | Active comparator | Drug: Personalised dosing of IV ganciclovirEnrolled participant will receive a personalised dosing of IV Ganciclovir calculated using an individualised IV ganciclovir dosing app, that considers the patient's weight, creatinine level, and at a target drug exposure (AUC24 between 40-100 mg.h/L), allowing for tailored dosing based on individual pharmacokinetic parameters. |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Immunocompromised patients including transplant recipients (haematopoietic stem cell transplant (HSCT), solid organ transplant (SOT)), those receiving chemotherapy or other immunosuppression or those with a known/suspected inborn error of immunity (determined by an immunologist); and
- Detectable clinically significant CMV viraemia and treating clinician determines that antiviral therapy is indicated.
- Willing to partake in the trial
- Willing/able to attend all follow up visits and capable of completing all trial assessments.
- Legally acceptable parent/guardian capable of providing consent on the participant's behalf.
Key exclusion criteria (9 listed)
- Current or prior CMV infection with documented genotypic resistance to GCV (UL97 and/or UL54); or
- Severe renal impairment (defined as estimated glomerular filtration rate (eGFR) <25mL/min); or
- Congenital CMV infection; or
- Life expectancy of less than 7 days as determined by the treating physician; or
- History of allergy, or adverse reaction to GCV, aciclovir or any component of the formulation; or
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard dosing of IV ganciclovirIV ganciclovir at standard dosing | Drug | Control: standard dosing |
| Personalised dosing of IV ganciclovirIV ganciclovir at a personalised dosing calculated using a ganciclovir dosing web app | Drug | Intervention: individualised dosing using a web app |
Primary outcome
The proportion of participants who achieve CMV virological clearance by 6 weeks
Time frame: 42 days
CMV virological clearance by 6 weeks to be compared between the two treatment groups. * Virological clearance defined as two consecutives negative CMV polymerase chain reaction results, or detectable but CMV viral load is less than the lower limit of detection. Separated by at least 72 hours by 6-weeks (42 days) after randomisation.
7 secondary outcomes
The proportion of participants who achieve CMV virological clearance before 3-weeks
Time frame: 21 days
The proportion of participants who develop CMV disease by 6 weeks
Time frame: 42 days
Difference between treatment groups in All-cause mortality by 6 months
Time frame: 6 months
The proportion of participants who develop drug resistant CMV infection by 6 months
Time frame: 6 months
The proportion of participants with treatment-related adverse effects (AEs)
Time frame: 42 days
Change in Quality of Life measured over 6 months using the EQ-5D-Y Questionnaire.
Time frame: 7 days, 42 days, 180 days
Difference between treatment groups in cost-effectiveness over the 6-month period following randomisation
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Background: PubMed 35111869Heston 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: PubMed 35242131Chan 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: PubMed 31448830El 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: PubMed 32712663Singh 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: PubMed 26209403Tan 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: PubMed 30502538Rastogi 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: PubMed 29217388Camargo 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: PubMed 36817745Acquier 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: PubMed 22062802Jang 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: PubMed 22198827Launay 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: PubMed 34610621Martson 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: PubMed 33373493Franck 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.
- National Ethics Advisory Committee. 2019. National Ethical Standards for Health and Disability Research and Quality Improvement. Wellington: Ministry of HealthLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Beginning 12 months following analysis and article publication, upon approval of the request, the following will be made available long-term for use by future researchers from a recognised research institution whose proposed use of the data has been ethically reviewed and approved by an independent committee and who accept MCRI's conditions for access: * Individual participant data that underlie the results reported in this article after deidentification (text, tables, figures, and appendices) * Trial protocol, Statistical Analysis Plan, PICF
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EBV Viremia, CMV Viremia
RecruitingPhase 2/3
Valganciclovir vs. Letermovir for CMV Prophylaxis in Heart Transplant
CMV Viremia, Heart Transplant Infection
Active, not recruitingPhase 1
CMV-MVA Triplex Vaccination of Stem Cell Donors in Preventing CMV Viremia in Participants With Allogeneic Transplant
Accelerated Phase CML, BCR-ABL1 Positive, Acute Lymphoblastic Leukemia in Remission
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amanda Gwee principal investigator
Murdoch Childrens Research Institute
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Standard dosing of IV ganciclovir and Personalised dosing of IV ganciclovir in people with Cytomegalovirus Viraemia, run by Murdoch Childrens Research Institute at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alice Lei (+61 0433 903 448, alice.lei2@rch.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of participants who achieve CMV virological clearance by 6 weeks (time frame: 42 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06574789, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.