[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617585":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":44,"responsibleParty":60,"collaborators":63,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":26,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":26,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":87,"overallStatus":88,"whyStopped":26,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Gadjah Mada University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A: Levofloxacin","EXPERIMENTAL","Receiving oral levofloxacin as infection prophylaxis during the induction phase, with the following dosage:\n\n* Age \\\u003C 5 years: 10 mg\u002Fkg PO every 12 hours (maximum 250 mg\u002Fdose)\n* Age ≥ 5 years: 10 mg\u002Fkg PO once daily (maximum 500 mg\u002Fday)",[13],"Drug: Levofloxacin",{"label":15,"type":16,"description":17,"interventionNames":18},"Group B: Placebo","PLACEBO_COMPARATOR","Receiving oral placebo at the same dosage as the treatment group.",[19],"Other: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Levofloxacin","younger than 5 years received levofloxacin 10 mg\u002Fkg by mouth every 12 hours and patients 5 years and older received 10 mg\u002Fkg by mouth once daily (maximum 500 mg\u002Fdose)",[9],null,{"type":6,"name":28,"description":17,"armGroupLabels":29,"otherNames":26},"Placebo",[15],[31],{"name":32,"affiliation":5,"role":33},"Idha Yulandari, M.D. Pediatric","PRINCIPAL_INVESTIGATOR",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":26,"email":39},"dr. Regina Amanda Putri, M.D","CONTACT","+6282322335677","reginamanda11@mail.ugm.ac.id",{"name":41,"role":37,"phone":42,"phoneExt":26,"email":43},"dr. Idha Yulandari, Sp.A, Fellow","+6281366659597","idhayulandari@gmail.com",[45],{"facility":46,"status":26,"city":47,"state":48,"zip":26,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"RSUP dr Sardjito","Sleman","DI Yogyakarta","Indonesia","ID",{"type":52,"coordinates":53},"Point",[54,55],110.35556,-7.71556,{"lat":55,"lon":54},[58],{"name":41,"role":37,"phone":59,"phoneExt":26,"email":43},"+62 813-6665-9597",{"type":33,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Idha Yulandari","Principal Investigator",[64],{"name":65,"class":66},"Dr. Sardjito Hospital, Yogyakarta","UNKNOWN","100617585","phase-4-levofloxacin-prophylaxis-to-prevent-first-febrile-neutropenia-in-pediatric-all-during-induction-phase-100617585",false,"NCT07320534","Levofloxacin Prophylaxis to Prevent First Febrile Neutropenia in Pediatric ALL During Induction Phase","The Effect of Levofloxacin Prophylaxis on the First Occurrence of Febrile Neutropenia During Induction Chemotherapy in Pediatric Patients With Acute Lymphoblastic Leukemia at Dr. Sardjito Hospital","Inclusion Criteria:\n\n* All patients aged 1 to 18 years diagnosed with acute lymphoblastic leukemia (ALL).\n* Receiving induction phase 1A chemotherapy for ALL using the Indonesian National Childhood ALL Pilot Protocol 2024 Standard Risk; induction phases 1A and 1B chemotherapy using the Indonesian National Childhood ALL Pilot Protocol 2024 High Risk; or induction chemotherapy using the ACT4ALL Protocol 2025 at Dr. Sardjito Hospital.\n* No history of allergy to levofloxacin.\n* Parents\u002Fguardians provide written informed consent.\n\nExclusion Criteria:\n\n* Death before initiation of chemotherapy.\n* Patients with clinically or microbiologically confirmed infection within 72 hours prior to induction chemotherapy who require antibiotics for more than 5 days (to avoid antibiotic therapy as a confounding factor for antibiotic prophylaxis).","ALL","6 Months","18 Years",{"count":78,"type":79},124,"ESTIMATED","INTERVENTIONAL",[82],"PHASE4","The goal of this clinical trial is To evaluate the benefit of levofloxacin prophylaxis in prolonging the median time to first febrile neutropenia in pediatric ALL patients during induction phase. It will also learn about the safety of levofloxacin during induction treatment.\n\nThe main questions it aims to answer are:\n\n* Does levofloxacin prophylaxis increase the median time to the first febrile neutropenia episode compared to placebo?\n* What are the rates of fever, severe infection, organ-related bacterial infection, and mortality in children receiving levofloxacin compared to placebo?\n\nResearchers will compare oral levofloxacin to a placebo (a look-alike substance with no active drug) to see if levofloxacin is effective in preventing infection during induction chemotherapy.\n\nParticipants will:\n\n* Be children aged 1 to 18 years with ALL undergoing induction chemotherapy.\n* Be randomly assigned to receive either levofloxacin prophylaxis or placebo during the induction phase.\n* Have regular checkups, physical exams, and laboratory tests during induction.\n* Be monitored for fever, febrile neutropenia, severe infections, bacterial infections, and mortality.\n* Stop prophylaxis once the first febrile neutropenia occurs or induction therapy is completed.",[85,86],"Neutropenic Fever","Acute Lymphoblastic Leukemia",[85,86,23],"NOT_YET_RECRUITING","2026-01-06",{"date":91,"type":92},"2026-01-08","ACTUAL",{"date":94,"type":79},"2026-01-01",{"date":96,"type":79},"2026-08-31",{"name":5,"class":6},1]