Micafungin versus Amphotericin B in Treatment of invasive Fungal Infection in Preterm Neonates: A Randomized Control Trial

Abstract

<title>Abstract</title> <bold>Background</bold> Micafungin, Amphotericin B, and Fluconazole are the primary therapeutic agents employed to address invasive fungal candidiasis in neonate. 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. <bold>Methods</bold> Fifty-six preterm neonates with invasive fungal infection proven by fungal culture and have received fluconazole for at least one week were included in our study and were divided randomly into two groups. Micafungin group: twenty-eight preterm neonates received Micafungin at dose of 8 mg/kg/day for 14 days. Amphotericin B group: twenty-eight preterm neonates received amphotericin B at a dose of 1 mg /kg/day for 14 days. Clinical and laboratory follow up by fungal culture was done after 14 days of treatment. <bold>Results</bold> Micafungin group showed significant increased percentage for complete cure of patients compared to Amphotericin B group 18(64.3%) vs 10(35.7%) respectively and decreased percentage of in complete cure compared to Amphotericin B 10(35.7%) vs 18(64.3%) respectively with p-value 0.030. No added drug side effects were seen with Micafungin except for mild hypomagnesemia. There was a significant increase in renal function after Amphotericin B treatment. <bold>Conclusion</bold> Micafungin is effective and well tolerated for treatment of invasive fungal infections in preterm neonates. <bold>Trial registration: </bold>The current study has been approved by clinical trials.org and the protocol ID: NCT06413056 retrospectively registered. <bold>https://clinicaltrials.gov/study/NCT06413056?cond=micafungin%20in%20neonates&amp;rank=2</bold>