NCT01887457

Individualisation of Voriconazole Antifungal Therapy Antifungal Therapy

PIVOTAL: Pharmacological Individualisation of VOriconazole Therapy for AntifungaL Treatment

• Status: Suspended
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: Brynn Chappell · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a trial to determine whether giving a patient a tailored dose of voriconazole is safe and effective.

Detailed description

Invasive fungal infections are a major cause of morbidity and mortality in patients with haematological malignancy and haematopoietic stem cell transplantation. Voriconazole is routinely used as a first-line agent for the treatment of invasive aspergillosis, invasive fusariosis and scedosporiosis. Voriconazole has extreme pharmacokinetic variability. Adult patients with a trough concentration of \< 1 mg/L have a lower probability of clinical response whereas patients with trough concentrations \> 6 mg/L a higher probability of toxicity. Therapeutic drug monitoring for dose adjustment is advocated but there are no algorithms that enable voriconazole dosage to be reliably adjusted to achieve desired trough concentrations in a timely and optimally precise manner. Novel ways to deliver optimised antifungal therapy are urgently required and this trial will evaluate whether giving a patients a tailored dose of voriconazole is safe and effective. Plasma concentrations will be taken in real time and inputted in dose software that will calculate an optimum dose for the required trough concentration of 1-3 mg/L. The software has been developed using data from phase I and III trials of voriconazole.

Conditions

• Immunocompromised Patient
• Aspergillosis
• Fusarium

Interventions

Type	Name	Description
DRUG	VFEND	voriconazole will be administered in iv form

Timeline

• Start date: 2014-09-01
• Primary completion: 2016-11-01
• Completion: 2016-12-01
• First posted: 2013-06-26
• Last updated: 2015-10-07

Locations

1 site across 1 country: United Kingdom