Micafungin Versus Amphotercine B in Treatment of Invasive Fungal Infection In Preterm Neonates: A Randomized Control Trial
Overview
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Ain Shams University
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- resolution of fungal infection
Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Randomized controlled, Double Blinded Clinical Trial.
Eligibility Criteria
- Ages
- 1 Day to 28 Days (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
micafungin group
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).
Intervention: Micafungin (Drug)
amphotericin B group
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).
Intervention: Amphotericin B (Drug)
Outcomes
Primary Outcomes
resolution of fungal infection
Time Frame: 14 days
negative blood culture
Secondary Outcomes
- complication(one month)
- morbidity(one month)
- mortality(one month)
Investigators
Mariam Ibrahim
Assistant Professor of Paediatrics, Ain Shams university
Ain Shams University