??Atorvastatin efficacy in the reduction of fungal infections in patients with Acute myeloid leukemia

Phase 3

Conditions: Acute myeloblastic leukaemia [AML].
Acute myeloblastic leukemia
C92.0

Registration Number: IRCT20210503051166N1

Lead Sponsor: Mashhad University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 76

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

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.