Micafungin versus Amphotericin B in treatment of invasive fungal infection in preterm neonates: a randomized control trial.

IF 3.2 3区医学 Q1 PEDIATRICS

Italian Journal of Pediatrics Pub Date : 2025-02-27 DOI:10.1186/s13052-025-01852-9

Mariam John Amin Ibrahim, Marwa Saad Mohammed Fathy, Mertte Ashraf Thabet Ghobrial, Maha Hassan Mohamed

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引用次数: 0

Abstract

Background: Micafungin, Amphotericin B, and Fluconazole are the primary therapeutic agents employed to address invasive fungal candidiasis in neonates. Resistance to fluconazole is gradually developing in neonatal intensive care units. We aimed to conduct a comparative analysis of Micafungin and Amphotericin B in terms of their effectiveness and safety in the treatment of invasive fungal infections in neonates.

Methods: Fifty-six preterm neonates with invasive fungal infection proven by fungal culture and who had received fluconazole for at least one week were included in our study and were divided randomly into two groups. Micafungin group: twenty-eight preterms received Micafungin at a dose of 8 mg/kg/day for 14 days. Amphotericin B group: twenty-eight preterms received amphotericin B at a dose of 1 mg /kg/day for 14 days. Clinical and laboratory follow up by fungal culture were performed after 14 days.

Results: Neonates in the Micafungin group showed significant increased percentage for complete cure of the fungal infection compared to Amphotericin B group 18(64.3%) vs. 10(35.7%) respectively and decreased percentage of incomplete cure 10(35.7%) vs. 18(64.3%) respectively with p-value 0.030. A higher percentage of neonates were completely cured for both candida albicans (65.2%) and non-albicans (60%) in the micafungin group. Duration of respiratory and circulatory support was significantly shorter also. No additional drug side effects were observed with Micafungin except for mild hypomagnesemia. There was an increase in blood urea nitrogen with Amphotericin B.

Conclusion: Micafungin is effective and well tolerated for the treatment of invasive fungal infections in preterm neonates.

Trial registration: The current study was approved by clinicaltrials.org and the protocol ID NCT06413056 was retrospectively registered in on 11th of march 2024. https://clinicaltrials.gov/study/NCT06413056?cond=micafungin%20in%20neonates&rank=2 .

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米卡芬净与两性霉素B治疗早产儿侵袭性真菌感染：一项随机对照试验

背景：米卡芬净、两性霉素B和氟康唑是治疗新生儿侵袭性念珠菌病的主要药物。新生儿重症监护病房对氟康唑的耐药性正在逐渐形成。我们的目的是对Micafungin和两性霉素B治疗新生儿侵袭性真菌感染的有效性和安全性进行比较分析。方法：选择56例经真菌培养证实为侵袭性真菌感染且给予氟康唑治疗1周以上的早产儿，随机分为两组。米卡芬金组：28例早产儿给予米卡芬金，剂量为8mg /kg/天，连续14天。两性霉素B组：28例早产儿给予两性霉素B，剂量为1mg /kg/天，连续14天。14天后进行临床和实验室真菌培养随访。结果：Micafungin组新生儿真菌感染完全治愈率分别高于两性霉素B组18（64.3%）和10(35.7%)，不完全治愈率分别低于10（35.7%）和18(64.3%)，p值分别为0.030。在米卡芬金组中，白色念珠菌（65.2%）和非白色念珠菌（60%）的新生儿完全治愈的比例更高。呼吸和循环支持的持续时间也明显缩短。除轻度低镁血症外，未观察到Micafungin的其他药物副作用。两性霉素b可使血尿素氮升高。结论：米卡芬宁治疗新生儿侵袭性真菌感染有效且耐受性良好。试验注册：目前的研究已由clinicaltrials.org批准，方案ID NCT06413056于2024年3月11日回顾性注册。https://clinicaltrials.gov/study/NCT06413056?cond=micafungin%20in%20neonates&rank=2。

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来源期刊

Italian Journal of Pediatrics PEDIATRICS-

CiteScore

6.10

自引率

13.90%

发文量

192

审稿时长

6-12 weeks

期刊介绍： Italian Journal of Pediatrics is an open access peer-reviewed journal that includes all aspects of pediatric medicine. The journal also covers health service and public health research that addresses primary care issues. The journal provides a high-quality forum for pediatricians and other healthcare professionals to report and discuss up-to-the-minute research and expert reviews in the field of pediatric medicine. The journal will continue to develop the range of articles published to enable this invaluable resource to stay at the forefront of the field. Italian Journal of Pediatrics, which commenced in 1975 as Rivista Italiana di Pediatria, provides a high-quality forum for pediatricians and other healthcare professionals to report and discuss up-to-the-minute research and expert reviews in the field of pediatric medicine. The journal will continue to develop the range of articles published to enable this invaluable resource to stay at the forefront of the field.