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NCT06810583
A Prospective Trial of Dalbavancin-Based Prophylaxis in Children and Adolescents With High-Risk Leukemia
Conditions: Leukemia, Acute Myeloid Leukemia, Lymphoblastic Leukemia in Children
Sex: All
Ages: N/A – 25 Years
Healthy volunteers: No
Phase: PHASE1
Enrollment: 29
Sponsor: St. Jude Children's Research Hospital
Location: St. Jude Children's Research Hospital Memphis Tennessee
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
Eligibility Criteria
Inclusion Criteria:
* Aged less than or equal to 25 years at enrollment
* Receiving treatment for AML or relapsed ALL at St. Jude and treatment is expected to cause prolonged (\> 7 days) severe neutropenia (ANC \< 500/ml)
* Expected to receive care at St. Jude for at least 56 days following enrollment on the protocol
* Female participant, greater than or equal to 9 years old, has a documented negative pregnancy test prior to receipt of study drug.
Exclusion Criteria:
* Allergy to vancomycin, dalbavancin, teicoplanin, levofloxacin or ciprofloxacin (Not including non-anaphylactic vancomycin infusion reaction)
* Documented past or current infection or colonization with pathogenic bacteria resistant to vancomycin plus either ciprofloxacin or levofloxacin, within the prior 6 months
* Diagnosed with long QT syndrome
* Any condition judged by the investigator to put the participant at high risk from participation
* Suspected or proven active bacterial infection
* Inability to complete requirements of participation in the study (in the opinion of the investigator)
* Expected survival \
Source: ClinicalTrials.gov (NCT06810583). StuddyBuddy aggregates publicly available trial information.