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

IF 3.1 2区医学 Q2 ONCOLOGY Cancer Medicine Pub Date : 2025-03-28 DOI:10.1002/cam4.70837

Roghayeh Savary-Kouzehkonan, Kourosh Sadeghi, Soroush Rad, Neda Alijani, Zohreh Baseri, Mohammad Vaezi, Seyed Asadollah Mousavi, Bita Shahrami

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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

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低剂量氟康唑对急性白血病侵袭性念珠菌感染初级预防的疗效：一项双盲随机临床试验

侵袭性真菌感染（IFIs），特别是念珠菌感染，是急性白血病患者发病和死亡的重要原因。虽然氟康唑广泛用于预防，但最佳给药方案仍不确定。本研究旨在评价低剂量氟康唑对急性白血病强化化疗患者侵袭性念珠菌感染一级预防的疗效。方法对急性白血病患者进行双盲随机临床试验。患者被分配接受低剂量（150mg /天）或标准高剂量（400mg /天）氟康唑，用于强化化疗期间侵袭性念珠菌感染的一级预防。主要结果是抗真菌预防的有效性和安全性。结果共纳入120例患者，每组60例。两组间念珠菌感染的总发生率相似（p = 0.615）。低剂量氟康唑组在第一周内念珠菌定植量较高，特别是口腔和腋下部位的非白色念珠菌（p < 0.001）。然而，到第三周，两组的定植量均显著下降，其中口腔定植量的减少具有统计学意义（p = 0.03）。曲霉病发生率为38.3%，两组间无显著差异（p > 0.99）。两组不良事件发生率相似（p > 0.05）。结论低剂量氟康唑是预防急性白血病患者念珠菌感染的有效替代方案，其疗效和安全性相似。曲霉病的威胁不断上升，突出表明需要有针对性地进行预防。需要进一步的研究来完善针对高危患者的策略。伊朗临床试验注册中心（IRCT）编号：IRCT20140818018842N37

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来源期刊

Cancer Medicine ONCOLOGY-

CiteScore

5.50

自引率

2.50%

发文量

907

审稿时长

19 weeks

期刊介绍： Cancer Medicine is a peer-reviewed, open access, interdisciplinary journal providing rapid publication of research from global biomedical researchers across the cancer sciences. The journal will consider submissions from all oncologic specialties, including, but not limited to, the following areas: Clinical Cancer Research Translational research ∙ clinical trials ∙ chemotherapy ∙ radiation therapy ∙ surgical therapy ∙ clinical observations ∙ clinical guidelines ∙ genetic consultation ∙ ethical considerations Cancer Biology: Molecular biology ∙ cellular biology ∙ molecular genetics ∙ genomics ∙ immunology ∙ epigenetics ∙ metabolic studies ∙ proteomics ∙ cytopathology ∙ carcinogenesis ∙ drug discovery and delivery. Cancer Prevention: Behavioral science ∙ psychosocial studies ∙ screening ∙ nutrition ∙ epidemiology and prevention ∙ community outreach. Bioinformatics: Gene expressions profiles ∙ gene regulation networks ∙ genome bioinformatics ∙ pathwayanalysis ∙ prognostic biomarkers. Cancer Medicine publishes original research articles, systematic reviews, meta-analyses, and research methods papers, along with invited editorials and commentaries. Original research papers must report well-conducted research with conclusions supported by the data presented in the paper.