[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594186":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":56,"collaborators":26,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":26,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":26,"maxAge":68,"enrollmentInfo":69,"targetDuration":26,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":81,"overallStatus":40,"whyStopped":26,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Gadjah Mada University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A","ACTIVE_COMPARATOR","Standard therapy IV ciprofloxacin 10 mg\u002FkgBW\u002F12 hours",[13],"Drug: Ciprofloxacin",{"label":15,"type":16,"description":17,"interventionNames":18},"Group B","EXPERIMENTAL","IV ceftazidime 150 mg\u002FkgBW\u002F24 hours divided into 3 doses",[19],"Drug: Ceftazidime",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Ceftazidime","Ceftazidime 150 mg\u002FkgBW\u002F24 hours divided into 3 doses.",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Ciprofloxacin","Ciprofloxacin 10 mg\u002FkgBW\u002F12 hours",[9],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"dr. Khairunisa Rahma Handayani, Medical doctor","CONTACT","+6281246572652","khairunisarahma99@mail.ugm.ac.id",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":26,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"RSUP dr Sardjito","RECRUITING","Sleman","DI Yogyakarta","Indonesia","ID",{"type":46,"coordinates":47},"Point",[48,49],110.35556,-7.71556,{"lat":49,"lon":48},[52],{"name":53,"role":34,"phone":54,"phoneExt":26,"email":55},"dr. Amanda Sari Puspita, Pediatric resident","+62 821-8300-4177","amanda.sari.p@mail.ugm.ac.id",{"type":57,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Bambang Ardianto","Principal Investigator, Head of Pediatric Hematolo-Oncology Divison","100594186","phase-4-ciprofloxacin-vs-ceftazidime-for-empirical-treatment-of-high-risk-neutropenic-fever-in-children-with-hematologic-malignancies-100594186",false,"NCT07016165","Ciprofloxacin vs Ceftazidime for Empirical Treatment of High-Risk Neutropenic Fever in Children With Hematologic Malignancies","Ciprofloxacin Versus Ceftazidime as Empirical Therapy of High-Risk Neutropenic Fever in Children With Hematologic Malignancies : A Randomized Controlled Trial","Inclusion Criteria:\n\n* Children aged 0 to 18 years with hematological malignancies.\n* Children with high-risk neutropenic fever, namely children with blood malignancies induction phase ALL, consolidation phase ALL, reinduction phase ALL, relapse ALL; meningeal ALL, AML, and NHL, diagnosed by a competent pediatrician on duty.\n* Consent from parents to be included in the study.\n\nExclusion Criteria:\n\n* Children with malignancies but accompanied by comorbidities (HIV infection, septic shock).\n* Allergy to ciproloxacin or ceftazidime.\n* Fever associated with blood transfusion reactions.\n* Receiving other antibiotics since 72 hours before being included in the study, except for cotrimoxazole prophylaxis for the prevention of Pneumocystis carinii pneumonia, and ciproloxacin prophylaxis in AML.\n* Children with blood malignancies who have impaired renal function (serum creatinine ≥ 1.5 times the upper normal limit) and impaired liver function (SGPT \\> 5 times the upper normal limit).","ALL","18 Years",{"count":70,"type":71},120,"ESTIMATED","INTERVENTIONAL",[74],"PHASE4","This clinical trial will compare use of ciprofloxacin and ceftazidime work in treating high-risk fever in children with hematological malignancies\n\n1. Does ceftazidime work better than ciprofloxacin as a first-choice antibiotic for children with hematological malignancies who have high-risk fever from low neutrophil count?\n2. Are there any specific factors that affect how children with hematological malignancies respond to ciprofloxacin or ceftazidime when treating high-risk fever?\n\nParticipants in this study are children with hematological malignancies who have a high risk of fever due to low neutrophil count. Children, aged 0 to 18 years old, will be hospitalized between June and December 2025 at Sardjito General Hospital\n\nThe study will involve:\n\n* Collecting patient history, conducting physical exams, and performing supporting tests.\n* Randomly assigning participants into two groups: one group will receive the standard treatment with intravenous ciprofloxacin, while the other group will receive the intervention treatment with intravenous ceftazidime.\n* Both groups will be monitored for various outcomes, including the length of fever, length of low white blood cell count, length of hospital stay, length of antibiotic use, any changes in antibiotics, and mortality.",[77,78,79,80],"Neutropenic Fever","Acute Lymphoblastic Leukemia","Acute Myeloblastic Leukemia","Non Hodgkin Lymphoma",[82,83,84,78,79,80],"ciprofloxacin","ceftazidime","neutropenic fever","2025-08-18",{"date":87,"type":88},"2025-08-22","ACTUAL",{"date":90,"type":88},"2025-06-01",{"date":92,"type":71},"2025-12-31",{"name":5,"class":6},1]