At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 29 enrolled
Drug / intervention
Prospective TDM Armdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Randomized Trial Comparing the Efficacy and Safety of Voriconazole Administered With Therapeutic Drug Monitoring vs. Standard Dosing
In Brief
A Phase 4 clinical trial evaluating Prospective TDM Arm for Fungal Infection. Completed, enrolled 29 participants across 1 site.
Detailed Summary
This is a prospective, multicenter, randomized trial to study therapeutic drug monitoring (TDM) of voriconazole among patients with an invasive mould infection (IMI). The primary objective of this study will be to assess the effect of prospective voriconazole TDM on the composite of adverse events (AE) and clinical response.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFungal Infection
CountriesUnited States
CollaboratorsPfizer
Timeline
Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 2011
Enrollment StartJan 2012
Primary CompletionDec 2014
TodayJul 2026
First PostedAug 12, 2011
Enrollment StartJan 1, 2012
Primary CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 14.9 years ago
Interventions
Prospective TDM Armdrug
Voriconazole dose will be adjusted based on per protocol obtained TDM levels