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L-AmB_ Retrospective mUlticenter Study on Mycosis prOphylaxis

Tolerability and Effectiveness of Extended Dosing of Liposomal Amphotericin B (L-AmB) for Primary Prophylaxis of Invasive Fungal Disease in High-risk Pediatric Patients: a Retrospective Multicenter Study

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06640296
Acronym
L-AmB_RUSCO
Enrollment
120
Registered
2024-10-15
Start date
2023-12-12
Completion date
2026-05-31
Last updated
2025-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Invasive Fungal Disease, Invasive Fungal Infections, Prophylaxis

Brief 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)

Detailed description

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). In this setting children presents some differences compared to adults in terms of risk factors for IFD: different treatment schemes, age-related comorbidities, diagnostic tools with different sensitivity. International guidelines strongly recommend primary prophylaxis in children at high risk of developing IFD to reduce disease-related morbidity and mortality (patients are considered to be at high risk in the presence of an IFD incidence ≥10%). Although the risk factors are well characterized in the literature and substantially unchanged over time, the local epidemiology must be considered in the evaluation of the best prophylaxis strategy. Drugs presently recommended for antifungal prophylaxis have been poorly studied in children, anyway triazoles (mainly posaconaozle) are indicated as possible prophylactic agents also in pediatrics. However, these drugs can present important interactions with drugs important for the treatment of pediatric leukemias (e.g. vinca alkaloids and posaconazole) and sometimes they lack of specific pediatric formulations, fact that can reduce compliance because of bad taste of the available formulations (oral solutions) or difficulties in swallowing and risk of poor absorption in presence of mucositis (bulky, non-divisible pills or capsules). 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 only which may require hospital access or activation of the home care team, but 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).

Interventions

collect data on tolerability and effectiveness of liposomal amphotericin B prophylaxis

Sponsors

Istituto Giannina Gaslini
Lead SponsorOTHER

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

Inclusion criteria

* all patients at high risk of developing IFD receiving chemotherapy for (1st line or relapse treatment) or allo-HSCT for which primary fungal prophylaxis with extended dosing of liposomal amphotericin B has been administered

Exclusion criteria

* previous diagnosis of IFD (secondary prophylaxis), * contraindications to liposomal amphotericin B prophylaxis

Design outcomes

Primary

MeasureTime frameDescription
Tolerability of extended dosing of liposomal amphotericin BIn the period between the first and last administration of L-AmBNumber of participants with treatment-related adverse events (both clinical and laboratoristic adverse events) as assessed by CTCAE v4.0

Secondary

MeasureTime frameDescription
Effectiveness of extended dosing of liposomal amphotericin BUp to 6 months after the last administration of L-AmBNumber of new diagnoses of IFD classified as proven, probable or possible according to EORTC/MSG criteria

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026