Clinical trial

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

Name
micafungin in neonates
Description
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.
Trial arms
Trial start
2022-10-20
Estimated PCD
2023-05-20
Trial end
2023-08-30
Status
Completed
Phase
Early phase I
Treatment
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
Arms:
micafungin group
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.
Arms:
amphotericin B group
Size
56
Primary endpoint
resolution of fungal infection
14 days
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Primary aim; to study the effectiveness of micafungin in treatment of fungal infection in preterm neonates.\n\nSecondary aim; to test the safety of micafungin in treatment of fungal infection in preterm neonates.\n\nTertiary aim; to compare the effectiveness and safety of micafungin versus amphotericin B in treatment of invasive fungal infection.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'Randomized controlled, Double Blinded Clinical Trial.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 56, 'type': 'ACTUAL'}}
Updated at
2024-05-16

1 organization

2 products

2 indications

Product
Micafungin