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

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 .