This phase I trial tests how well adding dalbavancin to standard ciprofloxacin or levofloxacin works in preventing bloodstream infections in children and adolescents receiving chemotherapy for acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) that has come back after a period of improvement (relapsed). Chemotherapy used to treat AML or relapsed ALL may put patients at higher risk of developing bloodstream infections during treatment. Fluorouquinolone antibiotics like ciprofloxacin and levofloxacin are commonly used to prevent infections in patients receiving chemotherapy but good evidence for their effectiveness, breakthrough infections remain relatively common. Adding dalbavancin to standard ciprofloxacin or levofloxacin may be more effective in preventing or controlling infections in patients receiving treatment for AML or relapsed ALL.
Additional locations may be listed on ClinicalTrials.gov for NCT06810583.
Locations matching your search criteria
United States
Tennessee
Memphis
Saint Jude Children's Research HospitalStatus: Active
Contact: Joshua Wolf
Phone: 901-595-3300
PRIMARY OBJECTIVE:
I. To estimate the rate of bacterial bloodstream infection in pediatric patients with AML or relapsed ALL undergoing chemotherapy receiving dalbavancin-based prophylaxis.
SECONDARY OBJECTIVES:
I. To describe the population pharmacokinetics of every 28 days dalbavancin up to 12 weeks in pediatric patients with AML or relapsed ALL undergoing chemotherapy.
II. To describe the tolerability of every 28 days dalbavancin prophylaxis in pediatric patients with AML or relapsed ALL undergoing chemotherapy.
III. To describe the acceptability of every 28 days dalbavancin prophylaxis in pediatric patients with AML or relapsed ALL undergoing chemotherapy.
IV. To estimate the rates of likely bacterial infections, Clostridioides difficile infection, and febrile neutropenia in pediatric patients receiving dalbavancin-based prophylaxis.
EXPLORATORY OBJECTIVES:
I. To describe the clinical and microbiological characteristics of bacteria causing bloodstream infections in pediatric patients receiving dalbavancin-based prophylaxis.
II. To describe the gastrointestinal resistome in pediatric patients receiving dalbavancin-based prophylaxis.
OUTLINE:
Patients receive dalbavancin intravenously (IV) once every 28 days for up to 3 doses in the absence of unacceptable toxicity, discontinuation of myelosuppressive chemotherapy or transfer to bone marrow transplant services. Patients also receive ciprofloxacin orally (PO) every 12 hours or levofloxacin PO or IV once daily (QD) or every 12 hours at the discretion of the treating clinician. Patients also undergo blood sample collection throughout the study.
After completion of study intervention, patients are followed up at day 84.
Lead OrganizationSaint Jude Children's Research Hospital
Principal InvestigatorJoshua Wolf
