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Anti-fungal agent

Personalized Dosing for Fungal Infections (PRAGMATIC Trial)

Phase 2

Waitlist Available

Research Sponsored by The University of Queensland

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed with haematological malignancy or disorder

Must not have

Post-allogeneic haematopoietic stem cell transplant (HCT) patient, without access to pre HCT DNA

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 8 to day 30

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to improve treatment for fungal infections in patients with blood cancer by using personalized dosing of voriconazole based on genetic testing. The study will determine if this approach is more effective than standard

Who is the study for?

This trial is for kids and adults with blood cancer who are dealing with invasive fungal infections. Participants must be able to undergo genotype testing, which will guide the dosing of voriconazole treatment.

What is being tested?

The study tests if personalized dosing of voriconazole, guided by genetic testing and special software, can better control fungal infections in blood cancer patients compared to standard care. It's a randomized trial where participants are split into groups by chance.

What are the potential side effects?

While specific side effects aren't listed here, voriconazole may commonly cause vision changes, rash, liver problems or hallucinations. Genetic testing has minimal risks like discomfort at the test site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with a blood cancer or disorder.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I had a stem cell transplant but don't have access to the DNA from before the transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 8 to day 30

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 8 to day 30

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 8 to day 30 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Therapeutic trough voriconazole concentration at Day 8

Secondary study objectives

All-cause mortality at 30 days

Clinical cure or stable disease

Clinical success

+16 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Precision CareExperimental Treatment1 Intervention

Voriconazole dosing will be initiated using current standard care dosing. Samples for TDM and genotype testing will be collected. Based on the results of these tests on Day 5, 8, 14, and up to day 30 ( ± 1 day) patients will be evaluated for dose adjustment using dosing software that includes patient data including TDM and genotype data.

Group II: Standard CareActive Control1 Intervention

Current standard of care at trial-site institutions uses weight-based (mg/kg) initial dosing of voriconazole, with dose adjustment based on standard therapeutic drug monitoring (TDM) results of measured voriconazole concentrations and based on clinical judgement.

0 / 2Eligibility criteria met