Single arm, single centre prospective study to assess the effect of therapeutic drug monitoring (TDM) based dosage adjustment of posaconazole on the incidence of invasive fungal infections (IFIs) in AML patients on induction chemotherapy on posaconazole prophylaxis

Tata Memorial Hospital0 个研究点目标入组 90 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•All newly diagnosed AML patients 18 years or above who are started remission induction therapy and started on posaconazole suspension for prophylaxis against invasive fungal infections during induction.

•1)Patients with invasive fungal infections at baseline who are already started on therapeutic doses of antifungals
•2)Patients on drugs, that are being taken for control of other comorbidites, that are known to lower the plasma concentrations of posaconazole eg. rifampicin/rifabutin , phenytoin, barbiturates or those drugs known to potentially interact with azole antifungals and cause life threatening adverse events (eg.terfenadine , cisapride, ebastine 24 hours prior to treatment or astemizole 10 days before treatment) (drug interactions with all other concomitant medication will be checked prior to enrolling the patient into the study)
•3)Patients with baseline deranged liver function tests at baseline i.e AST/ALT more than 5 times the upper limit of normal or total bilirubin level more than 3 times the upper limit of normal
•4)Patients with a previously known hypersensitivity or idiosyncratic reaction to any of the azole antifungals
•5)Baseline QTc interval more than 480 milliseconds on ECG

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