Micafungin Versus Amphotercine B in Treatment of Invasive Fungal Infection

Phase 4

Completed

• Conditions: Neonatal Infection; Invasive Fungal Infections
• Interventions: Drug: Micafungin; Drug: Amphotericin B

• Registration Number: NCT06413056
• Lead Sponsor: Ain Shams University

Brief Summary

The incidence of fungal infection has increased dramatically over the past few decades.This is due to increase in survival rates of preterm neonates, advances in medical technology and drug therapy, broad spectrum antibiotics and parenteral nutrition . The resistance to antifungal agents has increased. This study will assess the efficacy of micafungin versus amphotericin B in neonates with positive fungal culture.

Detailed Description

Neonatal candidiasis is associated with significant mortality and morbidity and high rates of neuro-developmental impairment on follow up Prevalence of invasive fungal infection (IFI) has increased in neonates during the last two decades due to increased survival rate even in the extremely premature neonates. Candida albicans and Candida parapsilosis are responsible for the majority of candidiasis in the neonatal intensive care unit (NICU) According to the European Society for Clinical Microbiology and Infectious Diseases (ESCMID)guidelines published in 2012, Micafungin, amphotericin B deoxycholate, and fluconazole are recommended as first line treatment of invasive candidiasis in neonates Currently, fluconazole and micafungin are among the most frequently used antifungal agents for the treatment of neonatal invasive candidiasis High dose of micafungin (8 to 15 mg/kg/day) can be used with neonates and infant with invasive candidiasis In this study we will explore the effectiveness and safety of micafungin for treatment of candidiasis after fluconazole for preterm neonates with invasive fungal infection and to compare it with amphotericin B.

Study Timeline

• Study Start: 2022-10-20
• Primary Completion: 2023-05-20
• Study Completion: 2023-08-30
• Study First Submitted: 2024-03-11
• Status Verified: 2024-05
• Study First Submitted QC: 2024-05-11
• Study First Posted: 2024-05-14
• Last Update Submitted: 2024-05-14
• Last Update Posted: 2024-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• Patient less than 36 weeks gestational age
• started fluconazole either prophylactic or therapeutic dose
• and blood culture is positive for fungal infection.

Exclusion Criteria

• Any neonate with hepatic dysfunction for any cause (hepatitis or hepatic failure), or with elevation in AST, ALT, alkhaline phosphatase
• Any neonate hypertensive, neutropenic, thrombocytopenic
• Any neonate with elevated renal function
• Any neonate with arrythmia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
micafungin group	Micafungin	Preterm neonate with fungal infection provened by fungal culture and who received fluconazole for at least one week will be divided into two groups. Will receive micafungin at a dose of 8 mg/kg/day for 14 day (Auriti et al., 2016).
amphotericin B group	Amphotericin B	Preterm neonate with fungal infection provened by fungal culture and who received fluconazole for at least one week will be divided into two groups. Will receive amphotericin B at a dose of 1 mg /kg/day for 14 days (chen et al.,2019).

Primary Outcome Measures

Name	Time	Method
resolution of fungal infection	14 days	negative blood culture

Secondary Outcome Measures

Name	Time	Method
complication	one month	drug complications
morbidity	one month	hospital stay
mortality	one month	death

Trial Locations

Locations (1)

Ain Shams University Hospitals; 🇪🇬 Cairo, Abbassia, Egypt