Comparison of high dose versus low dose of fluconazole for primary prevention of candida infections in patients with hematological malignancies, A single blind prospective randomized clinical trial

Phase 2

Recruiting

• Conditions: Occurrence of candidal infections (candidal colonization, superficial fungal infection, systemic fungal infection) in hematological malignancies,.

• Registration Number: IRCT20140818018842N37
• Lead Sponsor: Research Institute for Oncology, Hematology and Cell Therapy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 120

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).