Health Condition 1: null- Acute Myeloid Leukemia patients started on remission induction chemotherapy
Conditions
Interventions
Intervention1: Therapeutic Drug Monitoring (TDM) based dose adjustment of posaconazole in AML induction patients: AML patients who are started on remission induction chemotherapy and posaconazole prop
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1)To determine the percentage of patients achieving target posaconazole levels with therapeutic drug monitoring based dose adjustment. 2)To evaluate induction mortality. 3)Take up a cost effective analysis to see if the cost of TDM based dose adjustment of posaconazole is lesser than the cost of treating an invasive fungal infection. Timepoint: day 30 of induction | — |
Primary
| Measure | Time frame |
|---|---|
| Reduction in the incidence of invasive fungal infections during induction therapy phase of patients with AML on posaconazole prophylaxis with therapeutic drug monitoring based dose adjustment of posaconazole in comparison with the incidence in a historical cohort at our own center in which therapeutic drug monitoring based dose adjustment was not doneTimepoint: day 30 of induction | — |
Countries
India
Contacts
Public ContactDrMounika Boppana
Tata Memorial Hospital
Outcome results
None listed