Acute myeloblastic leukaemia [AML]. Acute myeloblastic leukemia
Conditions
Interventions
Intervention 1: "Intervention group:" In addition to the usual regimen for antifungal prophylaxis, atorvastatin tablets at a dose of 40 mg daily for 30 days will be administered. Intervention 2: Contr
Sponsors
Mashhad University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: patients with the diagnosis of AML who are candidate to receive 3+7 standard regimen patients who are candidate to receive anti fungal prophylaxis with fluconazole 400 mg daily Age between 18-75 years No other cancers No active or under treatment fungal infection No active or under treatment bacterial infection No prior use of statins No concomitant use of Cyclosporine, Cyprotrone AND/OR Danazole No use of any inhibitor/inducer of P-glycoprotein or CYP-3A4 which is contraindicated with the concomitant use of Atorvastatin
Exclusion criteria
Exclusion criteria: Prolonged Neutropenia ( ANC<500 more than 7 days) pregnancy Patient dissatisfaction with participating in the trial Hepatic Impairment based on the last liver function tests Creatinine clearance below 40 ml/min Known case of diabetes or random BS over 200 mg/dl History of hypersensitivity reactions with statins Diagnosis of Autoimmune diseases or any Acquired immunodeficiency except of chemotherapy induced neutropenia patients with positive HbS Ag, HbC Ab, HCV Ab or HIV Patient entry into other research projects
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of any fungal infection during hospitalization in the form of clinical signs approved by the treating physician. Timepoint: daily for 30 days. Method of measurement: Daily visit by the physician during hospitalization and then clinical evaluation for signs of infection for one month. To evaluate the infection, a physical examination should be performed by a physician and if any signs of fungal infections are found, additional tests including blood culture, urine and pulmonary secretions culture, biopsy of infectious lesions, imaging and evaluation of plasma galactomannan levels should be performed at the physician's discretion. | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of hospitalization. Timepoint: From the first day of hospitalization to discharge. Method of measurement: Number of hospitalization days.;The incidence of bacterial infection. Timepoint: Daily for 30 days. Method of measurement: Clinical evaluation. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactOmid Arasteh
Mashhad University of Medical Sciences
Outcome results
None listed