Micafungin Versus Amphotercine B in Treatment of Invasive Fungal Infection

Status Completed

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06413056
Study type	Interventional
Source	Ain Shams University
Contact
Status	Completed
Phase	Phase 4
Start date	October 20, 2022
Completion date	August 30, 2023

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04200807` - Non-invasive Measurement of Neonatal Central and Peripheral Hemodynamics
Recruiting	`NCT05695196` - Feasibility and Safety Study of Parent-to-Child Nasal Microbiota Transplant	Phase 1
Completed	`NCT01729000` - Study to Determine if Gloving in Addition to Hand Hygiene Will Prevent Invasive Infections and Necrotizing Enterocolitis	N/A
Completed	`NCT03247920` - Reduction of Intravenous Antibiotics In Neonates	Phase 4
Completed	`NCT02486783` - Infection, Sepsis and Meningitis in Surinamese Neonates	N/A
Recruiting	`NCT06194396` - Effect of Chlorhexidine Versus Alcohol on Infections in Neonates	N/A
Active, not recruiting	`NCT05343403` - Parental Participation on the Neonatal Ward - the neoPARTNER Study
Recruiting	`NCT04416373` - COVID-19 and Pregnancy Outcomes
Completed	`NCT01540162` - Experience of Mutaflor Suspension Use in Preterm Infants for Immunity Improvement	N/A
Withdrawn	`NCT03673566` - Clinical Evaluation of the "NICU Clinical Decision Support Dashboard" - CHMCO	N/A
Completed	`NCT04883801` - Clinical Outcomes of Newborns Born to Pregnant Women With and Without COVID-19
Terminated	`NCT05379452` - Outcomes of Neonates Born to Mothers With SARS-CoV-2 Infection in Shanghai
Active, not recruiting	`NCT04718220` - Safety, Testing/Transmission, and Outcomes in Pregnancies With COVID-19	N/A
Not yet recruiting	`NCT06102044` - Zinc Supplementation for Young Infants With Clinical Severe Infection in Tanzania	Phase 3
Active, not recruiting	`NCT04433364` - COPE - COVID-19 in Pregnancy and Early Childhood
Completed	`NCT03383211` - Immune Response to BCG Vaccination in Neonates Born to HIV and LTBI Infected and Non-infected Mothers
Completed	`NCT04893343` - Antibiotic Use in a Neonatal Intensive Care Unit Practicing Integrative Medicine
Withdrawn	`NCT03673579` - Clinical Evaluation of the "NICU Clinical Decision Support Dashboard" - MHSB	N/A
Completed	`NCT04206878` - Evaluating the Feasibility of Point of Care Birth Testing in Eswatini
Recruiting	`NCT05743816` - Neonatal Antimicrobial Resistance and Outcome