Prophylaxis of Febrile Neutropenia With Lactoferrin in Oncohematologic Children Undergoing Induction Chemotherapy
NCT07113314 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160
Last updated 2025-08-08
Summary
Test, in a randomized phase II trial, the safety and efficacy of lactoferrin prophylaxis in preventing the occurrence of febrile neutropenia and sepsis, with particular regard to forms due to multidrug-resistant Gram-negative bacteria.
Conditions
- Febrile Neutropenia (FN)
- Sepsis
- Chemotherapy Treatment
Interventions
- DIETARY_SUPPLEMENT
-
Lactoferrin Bovine
In addition to standard treatment, a gold-soluble formulation of bovine lactoferrin or bLF (Mosiac®) at the standard dose of 200 mg/day, in single administration, from the start of chemo/radiotherapy treatment and throughout the risk period.
Sponsors & Collaborators
-
Fondazione IRCCS Policlinico San Matteo di Pavia
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Max Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-10-06
- Primary Completion
- 2018-03-03
- Completion
- 2022-12-15
Countries
- Italy
Study Locations
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