A Trial Comparing Efficacy and Safety of Voriconazole Administered With Therapeutic Drug Monitori… (NCT01416025) | Clinical Trial Compass
CompletedPhase 4
A Trial Comparing Efficacy and Safety of Voriconazole Administered With Therapeutic Drug Monitoring vs. Standard Dosing
United States29 participantsStarted 2012-01
Plain-language 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.
Who can participate
Age range12 Years – 100 Years
SexALL
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Inclusion Criteria:
* Indication for voriconazole administration: proven, probable, or possible IMI, excluding zygomycosis (based on the revised EORTC/MSG consensus definitions) \[De Pauw, Clin Infect Dis. 2008; 46:1813\].
* Male or female ≥12 years of age.
* Evidence of a personally signed and dated informed consent document in accordance with local regulatory and legal requirements indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Exclusion Criteria:
* Known history of allergy, hypersensitivity or serious reaction to azole antifungals.
* Patients with aspergilloma or allergic bronchopulmonary aspergillosis (ABPA).
* Patients with chronic invasive aspergillosis with duration of symptoms or radiological finding for more than 4 weeks prior to study entry.
* Patients who are receiving and cannot discontinue the following drugs at least 24 hours prior to randomization: terfenadine, pimozide or quinidine (because of the possibility of QT prolongation), St John's wort preparation.
* Patients receiving any of the following medications: sirolimus, rifampin, rifabutin, carbamazepine, long acting barbiturates (e.g., phenobarbital, mephobarbital), ritonavir, efavirenz, or ergot alkaloids (e.g., ergotamine, dihydroergotamine).
* Receipt of more than 5 days of voriconazole as treat…