Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06640296
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-10-08
Brief Title:
L-AmB_ Retrospective MUlticenter Study on Mycosis PrOphylaxis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
L-AmB_RUSCO
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 mgkg every other day vs 25 mgkgdose twice-a-week vs 5 mgkgonce-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 eg 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 mgkg every other day vs 25 mgkgdose twice-a-week vs 5 mgkgonce-a-week
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None