Occurrence of candidal infections (candidal colonization, superficial fungal infection, systemic fungal infection) in hematological malignancies,.
Conditions
Interventions
Intervention 1: Intervention Group A: Patients receiving a low dose of oral fluconazole 150 mg once a day. Intervention 2: Intervention group B: Patients receiving a high dose of oral fluconazole 400
Sponsors
Research Institute for Oncology, Hematology and Cell Therapy
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age above 18 years All patients with hematological malignancies can receive a prophylactic regimen against Candida, including: Patients with acute leukemia undergoing primary induction or salvage chemotherapy with the possibility of developing Mucositis Patients with acute leukemia or Myelodysplastic syndromes (MDS) who are expected to experience severe and fatal neutropenia (ANC<500 for more than 7 days) following chemotherapy Having the informed consent of the patient to participate in the study
Exclusion criteria
Exclusion criteria: Patients with history of idiosyncratic hypersensitivity reaction to azoles Patients with disturbed liver tests with transaminases more than 10 times the normal limit Life expectancy less than 3 weeks History of treatment with systemic antifungal drugs in the last two weeks Patients who have been diagnosed with a fungal infection and are suffering from a fungal infection Pregnancy Patients with increased QTc interval or Torsades de pointes Patients receiving drugs with major clinical interaction (category X) with fluconazole Having a history of invasive fungal infection requiring systemic treatment in the last 6 months Failure to receive fluconazole for more than 3 days during the study Patients with renal failure as CrCl =50 mL/min breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of days receiving medicine for prophylaxis - the number of days the patient has been infected on preventive treatment. Timepoint: daily monitoring. Method of measurement: Questionnaire (checking the number of days). | — |
Secondary
| Measure | Time frame |
|---|---|
| The type of organism isolated from the culture (fungus). Timepoint: It varies according to the patient's condition. Method of measurement: 72 hours after an unexplained fever in a patient, despite the start of antibiotic therapy, a sample is sent for culture from blood, urine, and tissues suspected of fungal infection, and if the microorganism grows, the strain is isolated and identified.;The number of days that the patient has complications after taking the drug. Timepoint: daily monitoring. Method of measurement: Questionnaire (checking the number of days the patient has complications with the drug).;The type of complications with drug. Timepoint: daily monitoring. Method of measurement: Questionnaire (checking the type of complication caused by the drug).;The outcome of infection: death or patient recovery. Timepoint: daily monitoring. Method of measurement: Questionnaire (daily examination of the patient's clinical and laboratory conditions and the survival report of the patient on the days they receive the drug). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public Contactroghayeh savary kouehkonan
Tehran University of Medical Sciences
Outcome results
None listed