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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06574789




Registration number
NCT06574789
Ethics application status
Date submitted
20/08/2024
Date registered
28/08/2024

Titles & IDs
Public title
Individualised Dose Optimisation of Ganciclovir in Immunocompromised Children Trial (ID-MAGIC)
Scientific title
Individualised Dose Optimisation of Ganciclovir in Immunocompromised Children Trial (ID-MAGIC)
Secondary ID [1] 0 0
107507
Universal Trial Number (UTN)
Trial acronym
ID-MAGIC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cytomegalovirus Viraemia 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Standard dosing of IV ganciclovir
Treatment: Drugs - Personalised dosing of IV ganciclovir

Active comparator: Control: standard dosing - 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

Active comparator: Intervention: individualised dosing using a web app - 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.


Treatment: Drugs: Standard dosing of IV ganciclovir
IV ganciclovir at standard dosing

Treatment: Drugs: Personalised dosing of IV ganciclovir
IV ganciclovir at a personalised dosing calculated using a ganciclovir dosing web app
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The proportion of participants who achieve CMV virological clearance by 6 weeks
Timepoint [1] 0 0
42 days
Secondary outcome [1] 0 0
The proportion of participants who achieve CMV virological clearance before 3-weeks
Timepoint [1] 0 0
21 days
Secondary outcome [2] 0 0
The proportion of participants who develop CMV disease by 6 weeks
Timepoint [2] 0 0
42 days
Secondary outcome [3] 0 0
Difference between treatment groups in All-cause mortality by 6 months
Timepoint [3] 0 0
6 months
Secondary outcome [4] 0 0
The proportion of participants who develop drug resistant CMV infection by 6 months
Timepoint [4] 0 0
6 months
Secondary outcome [5] 0 0
The proportion of participants with treatment-related adverse effects (AEs)
Timepoint [5] 0 0
42 days
Secondary outcome [6] 0 0
Change in Quality of Life measured over 6 months using the EQ-5D-Y Questionnaire.
Timepoint [6] 0 0
7 days, 42 days, 180 days
Secondary outcome [7] 0 0
Difference between treatment groups in cost-effectiveness over the 6-month period following randomisation
Timepoint [7] 0 0
6 months

Eligibility
Key inclusion criteria
1. 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
2. Detectable clinically significant CMV viraemia and treating clinician determines that antiviral therapy is indicated.
3. Willing to partake in the trial
4. Willing/able to attend all follow up visits and capable of completing all trial assessments.
5. Legally acceptable parent/guardian capable of providing consent on the participant's behalf.
6. Treating clinician agreeable to child being enrolled in the trial.
Minimum age
1 Month
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Current or prior CMV infection with documented genotypic resistance to GCV (UL97 and/or UL54); or
2. Severe renal impairment (defined as estimated glomerular filtration rate (eGFR) <25mL/min); or
3. Congenital CMV infection; or
4. Life expectancy of less than 7 days as determined by the treating physician; or
5. History of allergy, or adverse reaction to GCV, aciclovir or any component of the formulation; or
6. Treating clinician determines that combination antiviral therapy is indicated for CMV infection; or
7. Has received >3 days of IV GCV or foscarnet or oral valganciclovir for the treatment of CMV infection prior to enrolment; or
8. Prior enrolment in the trial; or
9. Current recipient of another investigational product used for the treatment of CMV infection, as part of a clinical trial.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/10/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2028
Actual
Sample size
Target
232
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Sydney Children's Hospital - Sydney
Recruitment hospital [2] 0 0
The Children's Hospital at Westmead - Sydney
Recruitment hospital [3] 0 0
Queensland Children's Hospital - Brisbane
Recruitment hospital [4] 0 0
The Royal Children's Hospital - Melbourne
Recruitment hospital [5] 0 0
Monash Children's Hospital - Melbourne
Recruitment hospital [6] 0 0
Perth Children's Hospital - Perth
Recruitment postcode(s) [1] 0 0
2031 - Sydney
Recruitment postcode(s) [2] 0 0
2145 - Sydney
Recruitment postcode(s) [3] 0 0
4101 - Brisbane
Recruitment postcode(s) [4] 0 0
3052 - Melbourne
Recruitment postcode(s) [5] 0 0
3168 - Melbourne
Recruitment postcode(s) [6] 0 0
6009 - Perth
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
North Island

Funding & Sponsors
Primary sponsor type
Other
Name
Murdoch Childrens Research Institute
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Amanda Gwee
Address 0 0
Murdoch Children's Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Alice Lei
Address 0 0
Country 0 0
Phone 0 0
+61 0433 903 448
Fax 0 0
Email 0 0
alice.lei2@rch.org.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF)
When will data be available (start and end dates)?
Beginning 12 months following analysis and article publication, upon approval of the request
Available to whom?
Researchers must be 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
Available for what types of analyses?
How or where can data be obtained?


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/NCT06574789