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Micafungin Versus Amphotercine B in Treatment of Invasive Fungal Infection

Micafungin Versus Amphotercine B in Treatment of Invasive Fungal Infection In Preterm Neonates: A Randomized Control Trial

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06413056
Enrollment
56
Registered
2024-05-14
Start date
2022-10-20
Completion date
2023-08-30
Last updated
2024-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Invasive Fungal Infections, Neonatal Infection

Keywords

preterm, neonate, invasive fungal infection, micafungin

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.

Interventions

DRUGMicafungin

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 either micafungin or amphotericin B

DRUGAmphotericin 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.

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Randomized controlled, Double Blinded Clinical Trial.

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.

Eligibility

Sex/Gender
ALL
Age
1 Days to 28 Days
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

Design outcomes

Primary

MeasureTime frameDescription
resolution of fungal infection14 daysnegative blood culture

Secondary

MeasureTime frameDescription
complicationone monthdrug complications
morbidityone monthhospital stay
mortalityone monthdeath

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026