Clinical trial NCT06413056: Micafungin Versus Amphotercine B in Treatment of Invasive Fungal Infection
Official title: Micafungin Versus Amphotercine B in Treatment of Invasive Fungal Infection In Preterm Neonates: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neonatal Infection
Invasive Fungal Infections
Keywords: preterm
neonate
invasive fungal infection
micafungin
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-05-14
Enrollment: 56
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Primary aim; to study the effectiveness of micafungin in treatment of fungal infection in preterm neonates.

Secondary aim; to test the safety of micafungin in treatment of fungal infection in preterm neonates.

Tertiary aim; to compare the effectiveness and safety of micafungin versus amphotericin B in treatment of invasive fungal infection.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: resolution of fungal infection
timeFrame: 14 days
Secondary outcomes:
measure: complication
timeFrame: one month
measure: morbidity
timeFrame: one month
measure: mortality
timeFrame: one month
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Hospitals
state: Abbassia
Study officials:
References: