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Efficacy of Low-Dose Fluconazole for Primary Prophylaxis of Invasive Candida Infections in Patients With Acute Leukemia: A Double-Blind Randomized Clinical Trial Publisher Pubmed



Savarykouzehkonan R1 ; Sadeghi K1 ; Rad S2 ; Alijani N3 ; Baseri Z4 ; Vaezi M2 ; Mousavi SA2 ; Shahrami B1, 2, 5
Authors
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Authors Affiliations
  1. 1. Department of Clinical Pharmacy, School of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran
  2. 2. Hematology, Oncology, and Stem Cell Transplantation Research Center, Research Institute for Oncology, Hematology, and Cell Therapy, Tehran University of Medical Sciences, Tehran, Iran
  3. 3. Department of Infectious Disease, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran
  4. 4. Department of Microbiology, School of Medicine, Iran University of Medical Sciences, Tehran, Iran
  5. 5. Research Center for Rational Use of Drugs, Tehran University of Medical Sciences, Tehran, Iran

Source: Cancer Medicine Published:2025


Abstract

Background: Invasive fungal infections (IFIs), particularly Candida infections, are a significant cause of morbidity and mortality in patients with acute leukemia. While fluconazole is widely used for prophylaxis, the optimal dosing regimen remains uncertain. This study aimed to evaluate the efficacy of low-dose fluconazole for primary prophylaxis against invasive Candida infections in patients with acute leukemia receiving intensive chemotherapy. Methods: A double-blind, randomized clinical trial was conducted with patients diagnosed with acute leukemia. Patients were assigned to receive either low-dose (150 mg/day) or standard high-dose (400 mg/day) fluconazole for primary prophylaxis against invasive Candida infections during intensive chemotherapy. The primary outcomes were the efficacy of antifungal prophylaxis and the safety profile. Results: A total of 120 patients (60 per group) were enrolled. The overall incidence of Candida infections was similar between the groups (p = 0.615). Candida colonization was higher in the low-dose fluconazole group during the first week, particularly with non-albicans Candida at oral and subaxillary sites (p < 0.001). However, by the third week, both groups showed a significant decline in colonization, with the reduction in the oral cavity being statistically significant (p = 0.03). Aspergillosis occurred in 38.3% of patients, with no significant difference between groups (p > 0.99). Adverse events were similar in both groups (p > 0.05). Conclusion: Low-dose fluconazole is an effective alternative to high-dose regimens for preventing Candida infections in acute leukemia patients, with similar efficacy and safety. The rising threat of aspergillosis highlights the need for targeted prophylaxis. Further research is needed to refine strategies for high-risk patients. Trial Registration: Iranian Registry of Clinical Trials (IRCT) number: IRCT20140818018842N37. © 2025 The Author(s). Cancer Medicine published by John Wiley & Sons Ltd.