An observational study in Invasive Fungal Infections, Prophylaxis and Invasive Fungal Disease, sponsored by Istituto Giannina Gaslini. Enrolling by invitation at 1 site in Italy. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2025-05-04.
Sponsored by Istituto Giannina Gaslini · Observational
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Among 13 studies in Invasive Fungal Infections with a site in Italy — 2 open to participants now, 2 under way, none of them phase 3. Invasive Fungal Infections · Italy.
Among the 13 studies in Invasive Fungal Infections with a site in Italy, this one is the only one that started in 2023, is one of 6 observational ones, and was the 13th registered.
136 studies on the registry are indexed under Invasive Fungal Infections; 33 are open to participants now.
Browse Invasive Fungal Infections studies →2 of the 13 studies in Invasive Fungal Infections with a site in Italy are open now. Recruiting first, the newest first:
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · Sites in Italy
Ages 18+
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 20 Invasive Fungal Infections studies recruiting now, 12 (60%) set no upper age limit and 5 (25%) stop at 75 or younger; 9 take children under 18; 2 take healthy volunteers.
This study: Up to 18 Years · all sexes · no healthy volunteers.
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13 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 1 started in 2023.
This study's planned enrollment of 120 is close to the median of 125 across 66 observational studies indexed under Invasive Fungal Infections.
Median enrollment 252 across the 7 interventional studies, 332 across the 6 observational. Of the 9 that completed or were terminated, 2 (22%) have results posted.
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6 of 13 have an industry lead sponsor. The 10 most frequent:
Istituto Giannina Gaslini is the lead sponsor of 54 studies on the registry; 36 are open to participants now.
Istituto Giannina Gaslini has 1 study filed under Invasive Fungal Infections — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 13 studies in Invasive Fungal Infections with a site in Italy, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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)
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).
All pediatric patients who received extended dosing of liposomal amphotericin B prophylaxis from 01/01/2019 to 31/12/2023
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
patients at high risk of developing IFD receiving chemotherapy for (1st line or relapse treatment) or allo-HSCT for which primary fungal prophylaxis with Liposomal amphotericin B has been administered between 01/01/2019 to 31/12/2023
Drug: Liposomal Amphotericin B (LAmB)
collect data on tolerability and effectiveness of liposomal amphotericin B prophylaxis
Tolerability of extended dosing of liposomal amphotericin B
Number of participants with treatment-related adverse events (both clinical and laboratoristic adverse events) as assessed by CTCAE v4.0
Time frame: In the period between the first and last administration of L-AmB
Effectiveness of extended dosing of liposomal amphotericin B
Number of new diagnoses of IFD classified as proven, probable or possible according to EORTC/MSG criteria
Time frame: Up to 6 months after the last administration of L-AmB
Plan to share: Undecided
Started Dec 2023 (actual). Primary completion is estimated for Dec 2025, 24 months after the start.
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Istituto Giannina Gaslini