Individualised Dose Optimisation of Ganciclovir in Immunocompromised Children Trial (ID-MAGIC)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 232
- 试验地点
- 7
- 主要终点
- The proportion of participants who achieve CMV virological clearance by 6 weeks
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
- •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.
研究组 & 干预措施
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
干预措施: Standard dosing of IV ganciclovir (Drug)
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.
干预措施: Personalised dosing of IV ganciclovir (Drug)
结局指标
主要结局
The proportion of participants who achieve CMV virological clearance by 6 weeks
时间窗: 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.
次要结局
- Difference between treatment groups in All-cause mortality by 6 months(6 months)
- The proportion of participants who develop drug resistant CMV infection by 6 months(6 months)
- The proportion of participants who achieve CMV virological clearance before 3-weeks(21 days)
- The proportion of participants who develop CMV disease by 6 weeks(42 days)
- The proportion of participants with treatment-related adverse effects (AEs)(42 days)
- Change in Quality of Life measured over 6 months using the EQ-5D-Y Questionnaire.(7 days, 42 days, 180 days)
- Difference between treatment groups in cost-effectiveness over the 6-month period following randomisation(6 months)