Micafungin Versus Amphotercine B in Treatment of Invasive Fungal Infection

NCT ID: NCT06413056

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-20
• Study Completion Date: 2023-08-30

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.

Conditions

Neonatal Infection; Invasive Fungal Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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).

Group Type: EXPERIMENTAL

Micafungin

Intervention Type: 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 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).

Group Type: ACTIVE_COMPARATOR

Amphotericin B

Intervention Type: 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.

Interventions

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

Intervention Type: DRUG

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 28 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Mariam Ibrahim

Assistant Professor of Paediatrics, Ain Shams university

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ain Shams University Hospitals

Cairo, Abbassia, Egypt

Countries

Egypt

References

Ibrahim MJA, Mohammed Fathy MS, Ghobrial MAT, Mohamed MH. Micafungin versus Amphotericin B in treatment of invasive fungal infection in preterm neonates: a randomized control trial. Ital J Pediatr. 2025 Feb 27;51(1):61. doi: 10.1186/s13052-025-01852-9.

Reference Type: DERIVED

PMID: 40016807 (View on PubMed)

Other Identifiers

micafungin in neonates

Identifier Type: -

Identifier Source: org_study_id