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RECRUITING
NCT06810583
PHASE1

A Prospective Trial of Dalbavancin-Based Prophylaxis in Children and Adolescents With High-Risk Leukemia

Sponsor: St. Jude Children's Research Hospital

View on ClinicalTrials.gov

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

DRUG

Dalbavancin

3 doses of q28 days dalbavancin (12 weeks).

DRUG

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