[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neutropenic-fever\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neutropenic-fever":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,71],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"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":20,"type":21},124,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28],"Neutropenic Fever","Acute Lymphoblastic Leukemia",[27,28,30],"Levofloxacin","NOT_YET_RECRUITING","2026-01-06",{"date":34,"type":35},"2026-01-08","ACTUAL",{"date":37,"type":21},"2026-01-01",{"date":39,"type":21},"2026-08-31",{"name":41,"class":42},"Gadjah Mada University","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":18,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":54,"conditions":55,"keywords":58,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":43},"100594186","phase-4-ciprofloxacin-vs-ceftazidime-for-empirical-treatment-of-high-risk-neutropenic-fever-in-children-with-hematologic-malignancies-100594186","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).",{"count":52,"type":21},120,[24],"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.",[27,28,56,57],"Acute Myeloblastic Leukemia","Non Hodgkin Lymphoma",[59,60,61,28,56,57],"ciprofloxacin","ceftazidime","neutropenic fever","RECRUITING","2025-08-18",{"date":65,"type":35},"2025-08-22",{"date":67,"type":35},"2025-06-01",{"date":69,"type":21},"2025-12-31",{"name":41,"class":42},{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":18,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":22,"phases":80,"briefSummary":82,"conditions":83,"keywords":84,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":43},"100577132","antibiotic-stewardship-in-suspected-neutropenic-fever-asteric-trial-100577132","NCT06794320","Antibiotic Stewardship in Suspected Neutropenic Fever (ASTERIC Trial)","Antibiotic Stewardship in Suspected Neutropenic Fever (ASTERIC Trial): a Multi-centre, Type 1 Hybrid Effectiveness-implementation, Stepped-wedge, Randomised Controlled Trial","Inclusion Criteria:\n\n* ≥18 years\n* Tympanic temperature ≥38.3ºC within 24 hours before ED registration\n* Last chemotherapy or targeted therapy within 6 weeks for any solid tumour, or in any period following therapies against leukaemia, lymphoma, myelodysplastic syndrome, aplastic anaemia, multiple myeloma, or recipient of HSCT.\n\nExclusion Criteria:\n\n\\- The decision on how far to apply or deviate from a protocol rests with the clinician. Patients would be excluded from follow up if were unable or unwilling to provide informed consent for data access",{"count":79,"type":21},648,[81],"NA","Executive Summary\n\nBackground: Neutropenic Fever (NF), or febrile neutropenia, occurs in patients with early stage and metastatic solid tumours, non-leukaemic haematological cancers and acute leukaemia. It has a crude mortality rate of 3 to 18%. In Hong Kong, and in line with international guidelines, the target time from ED registration to ultra-broad spectrum antibiotic (UBSA) administration (door-to-antibiotic time, DTA time) is one hour disregarding the absolute neutrophil count (ANC). However, over 80% patients presenting to hospital with suspected NF (sNF) do not have NF and do not require UBSAs. Thus there is a need for evidence for a safe role for early treatments in patients with sNF to reduce unnecessary use of antibiotics.\n\nProtocol, Eligibility and Randomisation: This protocol describes the ASTERIC Trial, a pragmatic, multi-centre, type 1, hybrid effectiveness-implementation, stepped-wedge, before and after, cluster randomised controlled trial with variable baseline and follow up periods. Hospitals will be randomised to start dates comparing usual standard of care (SoC) (Period 1, before) with a new antibiotic stewardship protocol (Period 2, after). Hospitals, not patients, are randomised to variable start dates. The evidence for starting early UBSAs in patients with NF is well-established. What is unclear is how to optimise personalised care and the start times of UBSA when the majority of sNF patients do not have NF, there are delays to receiving an ANC report, and a proportion of patients might not need hospital admission.\n\nStudy design: a multi-centre, hybrid type 1 effectiveness-implementation trial which is an appropriate study design to evaluate the real-world effectiveness of an antibiotic stewardship protocol; and the barriers to and facilitators of its implementation in the ED setting.\n\nSettings: Eight hospitals in Hong Kong with patient involvement 24\u002F7.\n\nOutcomes: The Trial has two co-primary outcomes 1) mean total dose of UBSAs prescribed in 7 days and censored at 30 days from the time of randomisation; 2) safety (defined as the proportion of patients with a SAE), censored at 30 days from the time of randomisation.\n\nThis multifaceted trial addresses three broad domains of implementation according to Proctor's conceptual framework and taxonomy which incorporates the RE-AIM framework, namely: Service Outcomes; Implementation Outcomes and Client outcomes. Simplicity on the frontline: Patient enrolment and other front-line trial procedures will be streamlined. Informed consent is brief and simple and required for follow-up. Follow-up information may be ascertained by contacting participants in person, by phone or electronically, or by review of medical records and databases.\n\nData to be collected: Information will be collected on the patient, age, sex, major co-morbidity, sNF symptom onset date and severity, as well as any contraindications to study treatments. Follow-up information includes antibiotics - name, dose and duration; SAEs; mortality; sepsis; length of hospital stay; cost-effectiveness; patient satisfaction.\n\nNumbers: 648 patients (324 patients in each group) adult patients with sNF ≥38.3ºC and Modified Early Warning Score ≤6 within 24 hours of ED registration.\n\nBenefit to Healthcare\u002FExpected results: Study results will inform health policy with improvement in hospital services in treating stable sNF evidenced by improved personalised, safe antibiotic stewardship, early antibiotic de-escalation, early discharge, and reduced costs and length of stay. The ASTERIC protocol safely reduces the type, duration and dose of antibiotics.",[27],[85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102],"Antibiotic stewardship","Cancer","Carcinoma","Emergency care","Emergency department","Febrile Neutropenia","Health policy","Hematologic Neoplasms","Hospitalization","Length of stay","Meropenem","Neoplasms","Neutrophils","Oncology","Randomized Controlled Trial","RCT","Safety","Tumor","2025-01-20",{"date":105,"type":35},"2025-01-27",{"date":107,"type":21},"2025-02-01",{"date":109,"type":21},"2026-12-31",{"name":111,"class":42},"The University of Hong Kong"]