Phase
Condition
N/ATreatment
Personalised dosing of IV ganciclovir
Standard dosing of IV ganciclovir
Clinical Study ID
Ages 1-18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Immunocompromised patients including transplant recipients (haematopoietic stem celltransplant (HSCT), solid organ transplant (SOT)), those receiving chemotherapy orother immunosuppression or those with a known/suspected inborn error of immunity (determined by an immunologist); and
Detectable clinically significant CMV viraemia and treating clinician determinesthat antiviral therapy is indicated.
Willing to partake in the trial
Willing/able to attend all follow up visits and capable of completing all trialassessments.
Legally acceptable parent/guardian capable of providing consent on the participant'sbehalf.
Treating clinician agreeable to child being enrolled in the trial.
Exclusion
Exclusion Criteria:
Current or prior CMV infection with documented genotypic resistance to GCV (UL97and/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 theformulation; or
Treating clinician determines that combination antiviral therapy is indicated forCMV infection; or
Has received >3 days of IV GCV or foscarnet or oral valganciclovir for the treatmentof CMV infection prior to enrolment; or
Prior enrolment in the trial; or
Current recipient of another investigational product used for the treatment of CMVinfection, as part of a clinical trial.
Study Design
Study Description
Connect with a study center
Sydney Children's Hospital
Sydney, New South Wales 2031
AustraliaSite Not Available
The Children's Hospital at Westmead
Sydney, New South Wales 2145
AustraliaActive - Recruiting
Queensland Children's Hospital
Brisbane, Queensland 4101
AustraliaSite Not Available
Monash Children's Hospital
Melbourne, Victoria 3168
AustraliaSite Not Available
The Royal Children's Hospital
Melbourne, Victoria 3052
AustraliaActive - Recruiting
Perth Children's Hospital
Perth, Western Australia 6009
AustraliaActive - Recruiting
Starship Children's Hospital
Auckland, North Island 1023
New ZealandSite Not Available
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