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A Prospective Trial of Dalbavancin-Based Prophylaxis in Children and Adolescents With High-Risk Leukemia
Sponsor: St. Jude Children's Research Hospital
Summary
This is a single-arm pilot clinical trial evaluating dalbavancin-based prophylaxis in children and adolescents with acute myeloid leukemia or relapsed lymphoblastic leukemia receiving myelosuppressive chemotherapy. Primary objective: \- To estimate the rate of bacterial bloodstream infection in pediatric patients with AML or relapsed ALL undergoing chemotherapy receiving dalbavancin-based prophylaxis Secondary objectives: * To describe the population pharmacokinetics of every 28 days dalbavancin up to 12 weeks in pediatric patients with AML or relapsed ALL undergoing chemotherapy * To describe the tolerability of every 28 days dalbavancin prophylaxis in pediatric patients with AML or relapsed ALL undergoing chemotherapy * To describe the acceptability of every 28 days dalbavancin prophylaxis in pediatric patients with AML or relapsed ALL undergoing chemotherapy * To estimate the rates of likely bacterial infections, Clostridioides difficile infection, and febrile neutropenia in pediatric patients receiving dalbavancin-based prophylaxis
Official title: A Prospective, Single-Arm, Trial of Dalbavancin-Based Prophylaxis in Children and Adolescents With High-Risk Leukemia
Key Details
Gender
All
Age Range
Any - 25 Years
Study Type
INTERVENTIONAL
Enrollment
29
Start Date
2025-05-22
Completion Date
2031-09
Last Updated
2026-02-03
Healthy Volunteers
No
Interventions
Dalbavancin
3 doses of q28 days dalbavancin (12 weeks).
Fluoroquinolone (either ciprofloxacin or levofloxacin at the discretion of the treating clinician)
28 days dalbavancin plus fluoroquinolone (either ciprofloxacin or levofloxacin at the discretion of the treating clinician) for up to 3 doses (12 weeks).
Locations (1)
St. Jude Children's Research Hospital
Memphis, Tennessee, United States