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

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

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
* 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 \<28 days
* Alkaline phosphatase, alanine transferase or total bilirubin ≥ 3x upper limit of normal for age
* Estimated glomerular filtration rate (EGFR) \<30 mL/minute/1.73 m2
* Other absolute contraindication to administration of fluoroquinolone antibiotics or dalbavancin
* Participant is pregnant or breastfeeding a child

Conditions4

Locations1 site

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