NCT06810583 · St. Jude Children's Research Hospital
A Prospective Trial of Dalbavancin-Based Prophylaxis in Children and Adolescents With High-Risk Leukemia
What this study is about
This is a single-treatment group$1 pilot clinical trial evaluating dalbavancin-based prophylaxis in children and adolescents with acute myeloid leukemia or relapsed lymphoblastic leukemia receiving myelosuppressive chemotherapy.
View original scientific description
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.
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).
Primary outcome measures
Bacterial bloodstream infection
Time frame: Day 56
Proportion of evaluable participants with bacterial bloodstream infection with 95% confidence intervals
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Memphis, Tennessee
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 3, 2026 · Source of record for eligibility and locations