Pharmacologic optimization of voriconazole; a prospective cluster randomized controlled trial of therapeutic drug monitoring

Phase 4

Completed

• Conditions: invasive aspergillosis; Invasive fungal disease; 10017528

• Registration Number: NL-OMON40059
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 150

Inclusion Criteria

1) are at least 18 years of age
2) have received chemotherapy for haematological malignancies or have received a hematopoietic stem cell transplant
3) proven, probable or possible invasive fungal disease according to the EORTC/MSG criteria
4) treatment with voriconazole

Exclusion Criteria

1) allergic to voriconazole or its excipients
2) age below 18 years

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary clinical endpoint will be a global response consisting of a<br /><br>combined endpoint of toxicity and response to therapy (clinical, microbiologic<br /><br>and radiologic responses) 28 days after starting treatment with voriconazole.</p><br>