Individualisation of Voriconazole Antifungal Therapy Antifungal Therapy

NCT01887457 | Suspended Phase 2 DMC

• 2 other identifiers: 13_DOG06_1722013-002578-34
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Immunocompromised Patient; Aspergillosis; Fusarium

Keywords

voriconazole; VFEND; individualised; personalised

Outcome Measures

Primary Outcomes (1)

• Dose adjustment success

  Dose adjustment success will be evaluated by plasma trough concentration on day 5, successful dose adjustment is defined as a trough concentration of 1-3 mg/L of voriconazole.

  Day 5 of treatment

Secondary Outcomes (2)

• Mortality of patients

  35 Day after starting treatment

• Toxicity

  Day 5 of treatment and 35 day follow-up

Study Arms (1)

Voriconazole

EXPERIMENTAL

Standard adult Voriconazole (VFEND) Loading (1 hr infusion): 6mg/kg at 1 hour and 12 hours on day 1. Followed by standard maintenance dose 4mg/kg at 1 hour and 12 hours on day 2 (1 hour infusion). Day 3 follows the same schedule, expect the dose is adjusted, this dose is used on Day 4 and a further dose adjustment is made that is administered as above on Day 5.

Drug: VFEND

Interventions

VFEND DRUG

voriconazole will be administered in iv form

Also known as: voriconazole

Voriconazole

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any adult ≥18 years old
• Patients where a new course of voriconazole is indicated for suspected or confirmed invasive aspergillosis or other serious fungal infections that is deemed by the treating physician to be susceptible to voriconazole
• Patients must have venous access to permit the administration of voriconazole and enable the procurement of multiple plasma samples to measure voriconazole concentrations.
• Estimated creatinine clearance ≥ 50 mL/min
• Able to give written informed consent
• Considered fit to receive the trial treatment
• Able to remain in the hospital for at least 5 days or until they complete their trial treatment
• Female patients must satisfy the investigator that they are not pregnant, or are not of childbearing potential, or are using adequate contraception
• Men must also use adequate contraception

You may not qualify if:

• Patients with an estimated creatinine clearance \< 50 mL/minute (this precludes the use of intravenous voriconazole)
• Patients receiving any form of renal replacement therapy i.e. haemodialysis or haemofiltration
• Patients with hepatic insufficiency
• Female patients that are pregnant, breast feeding or planning pregnancy during the study
• Past history of intolerance to voriconazole
• Age \<18
• Evidence of a clinically relevant fungal isolate that is resistant to voriconazole
• QT prolongation on ECG
• Use of other medications that contraindicate the use of voriconazole
• Patients receiving any other medications that are contraindicated with the use of voriconazole i.e. terfenadine, long acting barbiturates, ergot alkaloids, etc. (Refer to SMPC). Only patients on rifampicin, rifabutin, phenytoin, and carbamazepine would have voriconazole precluded. Voriconazole influences with the pharmacokinetics of many additional agents- (see SMPC)- most importantly anti-rejection compounds- cyclosporine, tacrolimus\]
• Uncontrolled cardiac, respiratory or other disease or any serious medical or psychiatric disorder that would preclude trial therapy or informed consent.
• Hypersensitivity to Voriconazole, its excipients or other triazoles

Sponsors & Collaborators

• Brynn Chappell: lead
• The Christie NHS Foundation Trust: collaborator

Study Sites (1)

The Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

Location

Related Links

• Christie NHS website

MeSH Terms

Conditions

Aspergillosis

Interventions

Voriconazole

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• William Hope

  University of Liverpool

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Trials Project Manager

Study Record Dates

• First Submitted: June 7, 2013
• First Posted: June 26, 2013
• Study Start: September 1, 2014
• Primary Completion: November 1, 2016
• Study Completion: December 1, 2016
• Last Updated: October 7, 2015

Record last verified: 2015-10

Locations

GB (1)