Neonatal Infection Clinical Trial
Official title:
Micafungin Versus Amphotercine B in Treatment of Invasive Fungal Infection In Preterm Neonates: A Randomized Control Trial
Verified date | May 2024 |
Source | Ain Shams University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 56 |
Est. completion date | August 30, 2023 |
Est. primary completion date | May 20, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Day to 28 Days |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Egypt | Ain Shams University Hospitals | Cairo | Abbassia |
Lead Sponsor | Collaborator |
---|---|
Ain Shams University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | resolution of fungal infection | negative blood culture | 14 days | |
Secondary | complication | drug complications | one month | |
Secondary | morbidity | hospital stay | one month | |
Secondary | mortality | death | one month |
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