Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2026-01-04 @ 3:45 AM
Study NCT ID:
NCT01887457
Status:
SUSPENDED
Last Update Posted:
2015-10-07
First Post:
2013-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Individualisation of Voriconazole Antifungal Therapy Antifungal Therapy
Sponsor:
Brynn Chappell
Organization:
Study Overview
Official Title:
PIVOTAL: Pharmacological Individualisation of VOriconazole Therapy for AntifungaL Treatment
Status:
SUSPENDED
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Transfer of management of study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PIVOTAL
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2013-002578-34 | EUDRACT_NUMBER | None | View |