L-AmB_ Retrospective mUlticenter Study on Mycosis prOphylaxis
NCT06640296 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 120
Last updated 2025-05-04
Summary
Invasive fungal disease (IFD) still represents an important cause of morbidity and mortality in immunocompromised patients, particularly in patients undergoing antineoplastic chemotherapy or allogeneic hemopoietic stem cell transplantation (allo-HSCT). International guidelines recommend primary antifungal prophylaxis to reduce mortality and morbidity in these patients. Liposomal amphotericin B (L-AmB) can represent a valid alternative for antifungal prophylaxis in pediatric age as its spectrum is extended to both molds and yeasts, has reduced pharmacological interactions with the antineoplastic drugs most frequently used in treatment protocols. All this despite the availability of an intravenous formulation which can ensure complete compliance with the treatment. L-AmB prophylaxis has been proposed with different dosages: 1 mg/kg every other day vs 2.5 mg/kg/dose twice-a-week vs 5 mg/kg/once-a-week)
Conditions
- Invasive Fungal Infections
- Prophylaxis
- Invasive Fungal Disease
Interventions
- DRUG
-
Liposomal Amphotericin B (LAmB)
collect data on tolerability and effectiveness of liposomal amphotericin B prophylaxis
Sponsors & Collaborators
-
Istituto Giannina Gaslini
lead OTHER
Eligibility
- Max Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-12-12
- Primary Completion
- 2025-12-31
- Completion
- 2026-05-31
Countries
- Italy
Study Locations
More Related Trials
-
Micafungin Versus AmBisome in Invasive Candidiasis and Candidemia
NCT00106288 ·Status: COMPLETED ·Phase: PHASE3
-
Caspofungin Versus Fluconazole in Preventing Invasive Fungal Infections (IFI) in Patients Undergoing Chemotherapy for Acute Myeloid Leukemia
NCT01307579 ·Status: COMPLETED ·Phase: PHASE3
-
Study To Assess Pharmacokinetics, Safety & Efficacy of Anidulafungin When Treating Children With Invasive Candidiasis
NCT00761267 ·Status: COMPLETED ·Phase: PHASE3
-
A Randomized, Open, Comparative Multicenter Study of Initial Treatment With Intravenous Itraconazole Versus Amphotericin B Followed by Consolidation Treatment With Itraconazole Capsules in Patients With Blastomycosis or Histoplasmosis
NCT00002159 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Pharmacokinetics of Intravenous and Oral Posaconazole in Immunocompromised Children (MK-5592-097)
NCT02452034 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Efficacy, and Pharmacokinetics of Amphotericin B Lipid Complex
NCT01656382 ·Status: WITHDRAWN ·Phase: PHASE4
-
A Study of Safety and Pharmacokinetics of Repeated Dose of Micafungin as Antifungal Prophylaxis in Children and Adolescents Who Undergo Hematopoietic Stem Cell Transplant
NCT00606268 ·Status: COMPLETED ·Phase: PHASE1
-
Study of Mycamine® in Infants and Toddlers With Fungal Infections to Evaluate Safety and Blood Levels of the Drug
NCT00607763 ·Status: COMPLETED ·Phase: PHASE1
-
Oral Posaconazole Three Times Per Day vs Weekly High Dose Amphotericin B Lipid Complex (ABLC)
NCT00750737 ·Status: COMPLETED ·Phase: PHASE3
-
Posaconazole Versus Micafungin for Prophylaxis Against Invasive Fungal Infections During Neutropenia in Patients Undergoing Chemotherapy for Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia or Myelodysplastic Syndrome
NCT01200355 ·Status: COMPLETED ·Phase: PHASE4
-
Micafungin Prevention Study for Fungal Disease in Child Receiving Allogenic Hematopoietic Stem Cell Transplantation
NCT01135589 ·Status: UNKNOWN ·Phase: PHASE4
-
Use of Micafungin (Mycamine®) as Antifungal Prophylaxis in Haematology and Onco-haematology
NCT02127788 ·Status: COMPLETED
-
A Clinical Study on the Efficacy and Safety of ABCD in the Treatment of Patients With Invasive Fungal Disease
NCT06376201 ·Status: NOT_YET_RECRUITING ·Phase: PHASE4
-
CAMB/MAT2203 in Patients With Mucocutaneous Candidiasis
NCT02629419 ·Status: COMPLETED ·Phase: PHASE2
-
Liposomal Amphotericin B and Flucytosine Antifungal Strategy for Talaromycosis (LAmB-FAST)
NCT06525389 ·Status: NOT_YET_RECRUITING ·Phase: PHASE3
-
Amphotericin B Versus Isavuconazole for Mucormycosis: A Comparative Efficacy and Safety Study
NCT07191756 ·Status: ACTIVE_NOT_RECRUITING
-
Nebulised Liposomal Amphotericin for Invasive Pulmonary Aspergillosis (NAIFI01 Study)
NCT04267497 ·Status: COMPLETED ·Phase: PHASE1
-
A Pharmacokinetic Study of Pediatric Micafungin Prophylaxis
NCT02057289 ·Status: TERMINATED ·Phase: PHASE1
-
Micafungin Prevention Study for Invasive Fungal Disease in Pediatric & Adolescent Patients Undergoing Autologous Hematopoietic Stem Cell Transplantation
NCT01417169 ·Status: UNKNOWN ·Phase: PHASE2
-
CD101 Compared to Caspofungin Followed by Oral Step Down in Subjects With Candidemia and/or Invasive Candidiasis-Bridging Extension
NCT02734862 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety of Systematic Therapy and Bronchoscopic Interventional Treatment for Pulmonary Mucormycosis
NCT06495905 ·Status: ENROLLING_BY_INVITATION ·Phase: NA
-
Posaconazole (MK-5592) Intravenous and Oral in Children (<2 Years) With Invasive Fungal Infection (MK-5592-127)
NCT04665037 ·Status: RECRUITING ·Phase: PHASE2
-
A Study of the Safety, Tolerance, and Pharmacokinetics of Oral Posaconazole in Immunocompromised Children (P03579)
NCT01716234 ·Status: TERMINATED ·Phase: PHASE1
-
Micafungin Versus Amphotercine B in Treatment of Invasive Fungal Infection
NCT06413056 ·Status: COMPLETED ·Phase: PHASE4
-
Pharmacokinetics of Micafungin Given Twice Weekly Intravenously Compared to Micafungin Given Daily to Patients at Risk for Developing an Invasive Fungal Disease
NCT02172768 ·Status: COMPLETED ·Phase: PHASE2