Personalisation of Voriconazole therapy in Children(PVC)

• Research type

  Research Study

• Full title

  Prospective Phase IV study to observe the performance of controller software at predicting a trough concentration of voriconazole in paediatric patients. Personalisation of Voriconazole therapy in Children (PVC) study.

• IRAS ID

  143181

• Contact name

  Olya O'Connor

• Contact email

  olya.o'connor@nhs.net

• Sponsor organisation

  Research & Development Alder Hey Childrens Hospital

• Research summary

  Voriconazole is an important medicine for the treatment of life threatening fungal infections. The clinical use of voriconazole is limited by its excessive pharmacokinetic variability. Such erratic behaviour makes dosage adjustment in children especially difficult. The ability to estimate and control this pharmacokinetic variability would be a significant advance for the care of seriously ill children receiving voriconazole.
  This study is an observational validation study, aiming to test the ability of previously developed paediatric controller software to estimate pharmacokinetic variability and to predict desired concentration of voriconazole in paediatric population.
  The necessary tools to implement personalised voriconazole therapy for children are now available. A paediatric controller software has been developed in collaboration with the University of Southern California, and its performance has been tested in a single patient. We are now seeking to validate its performance in 10-20 immunocompromised children to provide the first critical step for more widespread use of controllers to provide tailored antifungal therapy.
  Alder Hey is one of the largest paediatric hospitals in the United Kingdom. Alder Hey has a recently established Clinical Research Facility funded by the National Institute for Health Research that provides the necessary infrastructure and governance to conduct clinical trials in paediatric patients. University of Liverpool has a validated voriconazole assay, and also has the necessary mathematical expertise to deliver this project and a demonstrated track record in state-of-the-art pharmacokinetic-pharmacodynamic modelling.
  This proposal is central to current notions of personalised antimicrobial chemotherapy. The construction of software that enables individualised antimicrobial therapy represents a significant advance in the care of immunocompromised patients by enabling the rapid achievement of drug concentrations that are known to be safe and effective.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  14/NW/0158

• Date of REC Opinion

  20 May 2014

• REC opinion

  Further Information Favourable Opinion