Micafungin Versus Amphotercine B in Treatment of Invasive Fungal Infection

Neonatal Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06413056
• Other study ID #: micafungin in neonates
• Status: Completed
• Phase: Phase 4
• Start date: October 20, 2022
• Est. completion date: August 30, 2023

Study information

• Verified date: May 2024
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: August 30, 2023
• Est. primary completion date: May 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 28 Days

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Invasive Fungal Infections
• Mycoses
• Neonatal Infection

Intervention

Drug:
• 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 either micafungin or amphotericin B
• 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.

Locations

Country	Name	City	State
Egypt	Ain Shams University Hospitals	Cairo	Abbassia

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	resolution of fungal infection	negative blood culture	14 days
Secondary	complication	drug complications	one month
Secondary	morbidity	hospital stay	one month
Secondary	mortality	death	one month