[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100578383":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":26,"centralContacts":30,"locations":35,"responsibleParty":53,"collaborators":21,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":21,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":21,"maxAge":63,"enrollmentInfo":64,"targetDuration":21,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":21,"overallStatus":37,"whyStopped":21,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"St. Jude Children's Research Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"q28 days dalbavancin plus fluoroquinolone","EXPERIMENTAL","Dalbavancin given at standard treatment doses once every 28 days in combination with standard of care fluoroquinolone (ciprofloxacin or levofloxacin) prophylaxis.",[13,14],"Drug: Dalbavancin","Drug: Fluoroquinolone (either ciprofloxacin or levofloxacin at the discretion of the treating clinician)",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Dalbavancin","3 doses of q28 days dalbavancin (12 weeks).",[9],null,{"type":17,"name":23,"description":24,"armGroupLabels":25,"otherNames":21},"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).",[9],[27],{"name":28,"affiliation":5,"role":29},"Joshua Wolf, MBBS","PRINCIPAL_INVESTIGATOR",[31],{"name":28,"role":32,"phone":33,"phoneExt":21,"email":34},"CONTACT","8662785833","referralinfo@stjude.org",[36],{"facility":5,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"RECRUITING","Memphis","Tennessee","38105","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-90.04898,35.14953,{"lat":47,"lon":46},[50],{"name":51,"role":32,"phone":52,"phoneExt":21,"email":34},"Rohith Jesudas, MBBS","866-278-5833",{"type":54,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100578383","phase-1-a-prospective-trial-of-dalbavancin-based-prophylaxis-in-children-and-adolescents-with-high-risk-leukemia-100578383",false,"NCT06810583","A Prospective Trial of Dalbavancin-Based Prophylaxis in Children and Adolescents With High-Risk Leukemia","A Prospective, Single-Arm, Trial of Dalbavancin-Based Prophylaxis in Children and Adolescents With High-Risk Leukemia","Inclusion Criteria:\n\n* Aged less than or equal to 25 years at enrollment\n* Receiving treatment for AML or relapsed ALL at St. Jude and treatment is expected to cause prolonged (\\> 7 days) severe neutropenia (ANC \\\u003C 500\u002Fml)\n* Expected to receive care at St. Jude for at least 56 days following enrollment on the protocol\n* Female participant, greater than or equal to 9 years old, has a documented negative pregnancy test prior to receipt of study drug.\n\nExclusion Criteria:\n\n* Allergy to vancomycin, dalbavancin, teicoplanin, levofloxacin or ciprofloxacin (Not including non-anaphylactic vancomycin infusion reaction)\n* Documented past or current infection or colonization with pathogenic bacteria resistant to vancomycin plus either ciprofloxacin or levofloxacin\n* Diagnosed with long QT syndrome\n* Any condition judged by the investigator to put the participant at high risk from participation\n* Suspected or proven active bacterial infection\n* Inability to complete requirements of participation in the study (in the opinion of the investigator)\n* Expected survival \\\u003C28 days\n* Alkaline phosphatase, alanine transferase or total bilirubin ≥ 3x upper limit of normal for age\n* Estimated glomerular filtration rate (EGFR) \\\u003C30 mL\u002Fminute\u002F1.73 m2\n* Other absolute contraindication to administration of fluoroquinolone antibiotics or dalbavancin\n* Participant is pregnant or breastfeeding a child","ALL","25 Years",{"count":65,"type":66},29,"ESTIMATED","INTERVENTIONAL",[69],"PHASE1","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.\n\nPrimary objective:\n\n\\- To estimate the rate of bacterial bloodstream infection in pediatric patients with AML or relapsed ALL undergoing chemotherapy receiving dalbavancin-based prophylaxis\n\nSecondary objectives:\n\n* To describe the population pharmacokinetics of every 28 days dalbavancin up to 12 weeks in pediatric patients with AML or relapsed ALL undergoing chemotherapy\n* To describe the tolerability of every 28 days dalbavancin prophylaxis in pediatric patients with AML or relapsed ALL undergoing chemotherapy\n* To describe the acceptability of every 28 days dalbavancin prophylaxis in pediatric patients with AML or relapsed ALL undergoing chemotherapy\n* To estimate the rates of likely bacterial infections, Clostridioides difficile infection, and febrile neutropenia in pediatric patients receiving dalbavancin-based prophylaxis",[72,73,74],"Leukemia","Acute Myeloid Leukemia","Lymphoblastic Leukemia in Children","2026-02-02",{"date":77,"type":78},"2026-02-03","ACTUAL",{"date":80,"type":78},"2025-05-22",{"date":82,"type":66},"2031-09",{"name":5,"class":6},1]