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Completed

NCT Number: NCT06413056

Micafungin Versus Amphotercine B in Treatment of Invasive Fungal Infection

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.

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Key information

Age range

1 day–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ain Shams University Hospitals

Cairo, Abbassia, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Micafungin

Drug

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

Drug

Preterm neonate with fungal infection provened by fungal culture and who received fluconazole for at least one week will be divided into two groups.

Primary outcomes

  1. resolution of fungal infection

    Time frame: 14 days

    negative blood culture

Secondary outcomes

  1. complication

    Time frame: one month

    drug complications

  2. morbidity

    Time frame: one month

    hospital stay

  3. mortality

    Time frame: one month

    death

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 14, 2024
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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