Micafungin Versus Amphotercine B in Treatment of Invasive Fungal Infection

NCT06413056 | Completed Phase 4

• 1 other identifier: micafungin in neonates
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Infection; Invasive Fungal Infections

Keywords

preterm; neonate; invasive fungal infection; micafungin

Outcome Measures

Primary Outcomes (1)

• resolution of fungal infection

  negative blood culture

  14 days

Secondary Outcomes (3)

• complication

  one month

• morbidity

  one month

• mortality

  one month

Study Arms (2)

micafungin group

EXPERIMENTAL

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).

Drug: Micafungin

amphotericin B group

ACTIVE COMPARATOR

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).

Drug: Amphotericin B

Interventions

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

micafungin group

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.

amphotericin B group

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patient less than 36 weeks gestational age
• started fluconazole either prophylactic or therapeutic dose
• and blood culture is positive for fungal infection.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospitals

Cairo, Abbassia, Egypt

Location

Related Publications (1)

• 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.

  PMID: 40016807 DERIVED

MeSH Terms

Conditions

Invasive Fungal Infections; Premature Birth

Interventions

Micafungin; Amphotericin B

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins; Echinocandins; Peptides, Cyclic; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomized controlled, Double Blinded Clinical Trial.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Paediatrics, Ain Shams university

Model Details: 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.

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: May 14, 2024
• Study Start: October 20, 2022
• Primary Completion: May 20, 2023
• Study Completion: August 30, 2023
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)