L-AmB_ Retrospective mUlticenter Study on Mycosis prOphylaxis

NCT06640296 | Enrolling By Invitation

• 1 other identifier: N. CET Liguria 366/2023
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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)

Conditions

Invasive Fungal Infections; Prophylaxis; Invasive Fungal Disease

Outcome Measures

Primary Outcomes (1)

• 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

  In the period between the first and last administration of L-AmB

Secondary Outcomes (1)

• Effectiveness of extended dosing of liposomal amphotericin B

  Up to 6 months after the last administration of L-AmB

Study Arms (1)

Patients at high risk of developing IFD

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)

Interventions

Liposomal Amphotericin B (LAmB) DRUG

collect data on tolerability and effectiveness of liposomal amphotericin B prophylaxis

Patients at high risk of developing IFD

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All pediatric patients who received extended dosing of liposomal amphotericin B prophylaxis from 01/01/2019 to 31/12/2023

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Istituto Giannina Gaslini: lead

Study Sites (1)

Istituto Giannina Gaslini

Genoa, 16146, Italy

Location

Related Publications (3)

• Donnelly JP, Chen SC, Kauffman CA, Steinbach WJ, Baddley JW, Verweij PE, Clancy CJ, Wingard JR, Lockhart SR, Groll AH, Sorrell TC, Bassetti M, Akan H, Alexander BD, Andes D, Azoulay E, Bialek R, Bradsher RW, Bretagne S, Calandra T, Caliendo AM, Castagnola E, Cruciani M, Cuenca-Estrella M, Decker CF, Desai SR, Fisher B, Harrison T, Heussel CP, Jensen HE, Kibbler CC, Kontoyiannis DP, Kullberg BJ, Lagrou K, Lamoth F, Lehrnbecher T, Loeffler J, Lortholary O, Maertens J, Marchetti O, Marr KA, Masur H, Meis JF, Morrisey CO, Nucci M, Ostrosky-Zeichner L, Pagano L, Patterson TF, Perfect JR, Racil Z, Roilides E, Ruhnke M, Prokop CS, Shoham S, Slavin MA, Stevens DA, Thompson GR, Vazquez JA, Viscoli C, Walsh TJ, Warris A, Wheat LJ, White PL, Zaoutis TE, Pappas PG. Revision and Update of the Consensus Definitions of Invasive Fungal Disease From the European Organization for Research and Treatment of Cancer and the Mycoses Study Group Education and Research Consortium. Clin Infect Dis. 2020 Sep 12;71(6):1367-1376. doi: 10.1093/cid/ciz1008.

  PMID: 31802125 BACKGROUND

• Bochennek K, Tramsen L, Schedler N, Becker M, Klingebiel T, Groll AH, Lehrnbecher T. Liposomal amphotericin B twice weekly as antifungal prophylaxis in paediatric haematological malignancy patients. Clin Microbiol Infect. 2011 Dec;17(12):1868-74. doi: 10.1111/j.1469-0691.2011.03483.x. Epub 2011 Sep 6.

  PMID: 21895857 BACKGROUND

• Groll AH, Pana D, Lanternier F, Mesini A, Ammann RA, Averbuch D, Castagnola E, Cesaro S, Engelhard D, Garcia-Vidal C, Kanerva J, Ritz N, Roilides E, Styczynski J, Warris A, Lehrnbecher T; 8th European Conference on Infections in Leukaemia. 8th European Conference on Infections in Leukaemia: 2020 guidelines for the diagnosis, prevention, and treatment of invasive fungal diseases in paediatric patients with cancer or post-haematopoietic cell transplantation. Lancet Oncol. 2021 Jun;22(6):e254-e269. doi: 10.1016/S1470-2045(20)30723-3. Epub 2021 Mar 31.

  PMID: 33811813 BACKGROUND

Related Links

• dictionary of the "Common Terminology Criteria for Adverse Events" of the National Cancer Institute

MeSH Terms

Conditions

Invasive Fungal Infections

Interventions

liposomal amphotericin B

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 15, 2024
• Study Start: December 12, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): May 31, 2026
• Last Updated: May 4, 2025

Record last verified: 2025-04

Locations

IT (1)