Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2025-12-25 @ 8:56 PM
Study NCT ID:
NCT06413056
Status:
COMPLETED
Last Update Posted:
2024-05-16
First Post:
2024-03-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Micafungin Versus Amphotercine B in Treatment of Invasive Fungal Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072742', 'term': 'Invasive Fungal Infections'}, {'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077551', 'term': 'Micafungin'}, {'id': 'D000666', 'term': 'Amphotericin B'}], 'ancestors': [{'id': 'D055666', 'term': 'Lipopeptides'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D054714', 'term': 'Echinocandins'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Randomized controlled, Double Blinded Clinical Trial.'}, 'primaryPurpose': 'TREATMENT', '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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-14', 'studyFirstSubmitDate': '2024-03-11', 'studyFirstSubmitQcDate': '2024-05-11', 'lastUpdatePostDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'resolution of fungal infection', 'timeFrame': '14 days', 'description': 'negative blood culture'}], 'secondaryOutcomes': [{'measure': 'complication', 'timeFrame': 'one month', 'description': 'drug complications'}, {'measure': 'morbidity', 'timeFrame': 'one month', 'description': 'hospital stay'}, {'measure': 'mortality', 'timeFrame': 'one month', 'description': 'death'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['preterm', 'neonate', 'invasive fungal infection', 'micafungin'], 'conditions': ['Neonatal Infection', 'Invasive Fungal Infections']}, 'referencesModule': {'references': [{'pmid': '40016807', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '28 Days', 'minimumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient less than 36 weeks gestational age\n* started fluconazole either prophylactic or therapeutic dose\n* and blood culture is positive for fungal infection.\n\nExclusion Criteria:\n\n* Any neonate with hepatic dysfunction for any cause (hepatitis or hepatic failure), or with elevation in AST, ALT, alkhaline phosphatase\n* Any neonate hypertensive, neutropenic, thrombocytopenic\n* Any neonate with elevated renal function\n* Any neonate with arrythmia'}, 'identificationModule': {'nctId': 'NCT06413056', 'briefTitle': 'Micafungin Versus Amphotercine B in Treatment of Invasive Fungal Infection', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Micafungin Versus Amphotercine B in Treatment of Invasive Fungal Infection In Preterm Neonates: A Randomized Control Trial', 'orgStudyIdInfo': {'id': 'micafungin in neonates'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'micafungin group', 'description': '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).', 'interventionNames': ['Drug: Micafungin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'amphotericin B group', 'description': '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).', 'interventionNames': ['Drug: Amphotericin B']}], 'interventions': [{'name': 'Micafungin', 'type': 'DRUG', 'description': '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', 'armGroupLabels': ['micafungin group']}, {'name': 'Amphotericin B', 'type': 'DRUG', 'description': 'Preterm neonate with fungal infection provened by fungal culture and who received fluconazole for at least one week will be divided into two groups.', 'armGroupLabels': ['amphotericin B group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'state': 'Abbassia', 'country': 'Egypt', 'facility': 'Ain Shams University Hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Paediatrics, Ain Shams university', 'investigatorFullName': 'Mariam Ibrahim', 'investigatorAffiliation': 'Ain Shams University'}}}}