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

Background

Invasive fungal infections (IFIs), especially Candida infections, can be very serious for patients with acute leukemia. Fluconazole is commonly used to prevent these infections, but the best dosage is still unclear.

Study Purpose

This study looked at how effective low-dose fluconazole is in preventing Candida infections in patients with acute leukemia undergoing intensive chemotherapy.

Study Design

We conducted a double-blind, randomized clinical trial with patients diagnosed with acute leukemia. Participants received either:

  • Low-dose fluconazole (150 mg/day)
  • Standard high-dose fluconazole (400 mg/day)

Results

A total of 120 patients participated, with 60 in each group. The results showed:

  • Similar rates of Candida infections in both groups (p = 0.615).
  • Higher Candida colonization in the low-dose group during the first week, especially with non-albicans types (p < 0.001).
  • By the third week, both groups had a significant decrease in colonization, particularly in the mouth (p = 0.03).
  • Aspergillosis affected 38.3% of patients, with no significant differences between groups (p > 0.99).
  • Adverse events were similar in both groups (p > 0.05).

Conclusion

Low-dose fluconazole is a good alternative to high-dose fluconazole for preventing Candida infections in patients with acute leukemia. Both options showed similar effectiveness and safety. However, the risk of aspergillosis remains a concern, indicating a need for targeted prevention strategies.

Next Steps

Further research is necessary to improve prevention strategies for high-risk patients.

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