Gastrointestinal Implications of Voriconazole Exposure
Withdrawn before enrolling
Conditions studied: Infection
In brief
Voriconazole has better response rates, improved survival and less adverse side effects compared to other drugs for the treatment of invasive fungal infections making it a desirable therapeutic option for children. However, dosing is unpredictable in children and this leads to therapeutic failure. This study aims to understand the physiological differences between children and adults that leads to therapeutic failure of voriconazole in children.
Key facts
- Study ID
- NCT02904434
- Run by
- Children's Hospital of Philadelphia
- People needed
- 0
- Starts
- 2016-09-01
- Expected to finish
- 2020-06-01
- Last updated by the study team
- 2020-04-09
Who can join
Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Children aged 2-17 years old
- Receiving oral voriconazole as standard of care and at steady-state concentrations (defined as 72 hours from first-dose or 72 hours with no dose change)
- Informed Consent/Assent when appropriate
You may not qualify if…
- Allergy or inability to receive the slushy solution, which will be prepared using commercially available frozen grapefruit juice concentrate, cherry syrup, and Sprite.
- Receiving tacrolimus and/or cyclosporine, which are affected by the furanocoumarins, during study period
- Suspected or known hepatic dysfunction (defined as liver function tests measured at 3x upper limit of normal within the past 1 month, when measured as standard of care)
- Receiving renal replacement therapy (example peritoneal dialysis, hemodialysis, continuous veno-venous hemofiltration, continuous veno-venous hemodialysis)
- Receiving therapy with extracorporeal membrane oxygenation (ECMO)
- Patients with documented pancytopenia, diarrhea, mucositis, or active infection
Where it is running
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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