[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"febrile-neutropenia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:febrile-neutropenia":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,47,74,104,128,149,170,202,227,249,279,302],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100614268","plasma-host-microbe-proteomics-to-predict-complications-in-high-risk-febrile-neutropenia-100614268",false,"NCT07277387","Plasma Host-Microbe Proteomics to Predict Complications in High-risk Febrile Neutropenia","A Multicenter Prospective Observational Study on the Plasma Proteomic Profiling of Human and Microbial Proteins for the Early Identification of Biomarker Combinations (Combitypes) Associated With Complications in Oncohematologic Patients With Febrile Neutropenia","Inclusion Criteria:\n\n* Adults (≥18 years).\n* Written informed consent provided by patient or legal representative.\n* Diagnosis of hematologic malignancy under induction chemotherapy, post-allogeneic hematopoietic stem cell transplantation, or CAR-T therapy.\n* High-risk febrile neutropenia (ANC ≤ 100 cells\u002Fmm³, expected duration ≥ 7 days, or significant comorbidities).\n* Fever defined as oral temperature ≥38.3 °C once or ≥38.0 °C for ≥1 hour.\n* Hospitalized or requiring immediate admission at the time of FN diagnosis.\n\n  ´- Initial uncomplicated clinical presentation, with no previous infection or colonization by multidrug-resistant bacteria.\n* Eligible for initial monotherapy with broad-spectrum empirical antibiotic.\n* Availability for serial plasma sampling and clinical follow-up.\n\nExclusion Criteria:\n\n* Age \\\u003C18 years.\n* Low-risk FN according to MASCC\u002FCISNE criteria.\n* Initial sample collected after antibiotic administration.\n* Decline or inability to provide informed consent.\n* Any condition preventing safe participation or reliable sample collection.\n* Fever induced by noninfectious causes (considered as adjustment factor, not exclusion).","ALL","18 Years",{"count":19,"type":20},350,"ESTIMATED","30 Days","OBSERVATIONAL","Febrile neutropenia (FN) is a common oncologic emergency in patients with hematologic malignancies, associated with high morbidity and mortality. Early identification of patients at higher risk of complications such as sepsis or septic shock is critical to optimize antimicrobial management.\n\nThis study aims to characterize the human and microbial plasma proteome using high-resolution mass spectrometry to identify biomarker combinations (\"combitypes\") capable of predicting complications in oncohematologic patients with FN.\n\nA cohort of 350 adult patients with high-risk FN and initially uncomplicated clinical presentation will be enrolled across three tertiary hospitals. Plasma samples will be collected at fever onset (before antibiotic initiation) and after 48 hours. Proteomic data will be integrated with clinical information using multivariate and machine learning models to develop a predictive model for complications.",[25],"Febrile Neutropenia",[27,28,29,30,31,32,33],"febrile neutropenia","hematologic malignancy","proteomics","sepsis","biomarkers","septic shock","mass spectrometry","RECRUITING","2026-06-11",{"date":37,"type":38},"2026-06-15","ACTUAL",{"date":40,"type":38},"2026-06-09",{"date":42,"type":20},"2029-01",{"name":44,"class":45},"Instituto de Investigación Biomédica de Salamanca","OTHER",3,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":62,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":73},"100566592","ecm-and-monitoring-w-alio-smart-patch-in-cancer-pts-receiving-chemotherapy-100566592","NCT06657183","ECM and Monitoring w\u002F Alio Smart Patch in Cancer Pts Receiving Chemotherapy","Enhanced Care Management (ECM) and Continuous Monitoring of Vital Signs With Alio Smart Patch Wearable Sensor in Adult Cancer Patients Receiving Chemotherapy With Moderate or High Risk of Febrile Neutropenia or Immunotherapy","Inclusion Criteria:\n\n* Individuals must meet all of the following inclusion criteria in order to be eligible to participate in the study:\n* Subjects have a diagnosis of soft tissue sarcoma, NSCLC, HNSCC, breast, pancreatic cancer, or melanoma\n* For Cohort 1 (n=15), participants are eligible if starting on a new chemotherapy regimen with either: (i) high risk (\\> 20%) of febrile neutropenia as per NCCN MGF guidelines; or (ii) intermediate risk for febrile neutropenia AND one or more risk factors for febrile neutropenia:\n\n  * Age \\> or equal to 65 years\n  * Advanced disease\n  * Previous Chemotherapy or Radiation therapy\n  * Preexisting neutropenia or bone marrow involvement with tumor\n  * Infection\n  * Open wounds or surgery in last 4 weeks\n  * Poor performance status or poor nutritional status\n  * Poor renal function (cr clearance \\\u003C50)\n  * Total Bilirubin \\>1.5 upper limit of normal\n  * Cardiovascular Disease\n  * Multiple Co-morbidities\n  * HIV infection\n  * BMI \\> 2.0\n* For Cohort 2 (n=15) participants are eligible if starting on immunotherapy alone, or concurrent chemo-immunotherapy.\n* Participants are capable of giving informed consent\n* Participants must be able to read and\u002For to speak English\n* Participants who are 18 years of age or older\n* Expected chemotherapy treatment duration of at least 12 weeks\n\nExclusion Criteria:\n\n* An individual who meets any of the following criteria will be excluded from participation in this study:\n\n  * Participants who cannot read or speak English\n  * Participants without any cellphone access","65 Years",{"count":56,"type":20},30,"INTERVENTIONAL",[59],"NA","Undergoing cancer treatment comes with various risks and side effects. This clinical trial aims to reduce those risks and side effects through continuous monitoring of vital signs and blood levels. The goal is to see if potential side effects can be identified and treated sooner.\n\nDuring this study, participants will wear an Alio Smartpatch™. The Alio Smartpatch™ is a wireless remote monitoring system. This device will measure participants' vital signs and blood levels. Participants will also be asked to use continuous glucose monitors to measure their glucose levels. The data collected on each participant from these devices will be remotely monitored at all times by clinical staff at a company known as Quantify Remote Care. If a participant's results look like they are experiencing a side effect, the participant will be contacted immediately by Quantify Remote Care team. The Quantify Remote Care team will function as an extension of the participant's cancer clinical team and will relay any significant issues back to them. Quantify Health also provides dietary and mental health support as needed for all participants.",[25],[63],"Alio Smart Patch","2026-05-06",{"date":66,"type":38},"2026-05-08",{"date":68,"type":38},"2025-08-06",{"date":70,"type":20},"2026-10",{"name":72,"class":45},"Case Comprehensive Cancer Center",1,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":54,"enrollmentInfo":81,"targetDuration":4,"studyType":57,"phases":83,"briefSummary":84,"conditions":85,"keywords":89,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":73},"100554563","acupuncture-as-add-on-to-g-csf-for-febrile-neutropenia-related-hospitalization-in-doxorubicin-treated-patients-with-sarcoma-100554563","NCT06500715","Acupuncture as add-on to G-CSF for Febrile Neutropenia-related Hospitalization in Doxorubicin-treated Patients With Sarcoma","Acupuncture as add-on to GCS-F Treatment for Reducing Febrile Neutropenia-related Hospitalization in Patients Undergoing Doxorubicin-based Treatment for Sarcoma: a Randomized Crossover Study","Inclusion Criteria:\n\n* age 18-65 years\n* diagnosed with sarcoma of any stage\n* scheduled for doxorubicin-based chemotherapy\n* function ECOG status score of 0-1\n\nExclusion Criteria:\n\n* not fulfilling all inclusion criteria\n* unwilling or unable to provide written informed consent for study participation",{"count":82,"type":20},60,[59],"Chemotherapy-induced febrile neutropenia (CIFN) is a dangerous complication of many chemotherapy drugs, with current treatment with granulocyte colony-stimulating factors (G-CSFs) accompanied by adverse effects, primarily muscle and bone pain. Adult patients with sarcoma treated with doxorubicin-based chemotherapy have a high risk (\\>40%) for developing CIFN. Acupuncture has been shown to have a potentially myelo-protective effect on bone marrow during chemotherapy, though its effect on the incidence of CIFN-related hospitalization has yet to be examined. In the proposed study, patients with sarcoma will be randomly allocated (in a ratio of 1:1) to Group A, receiving acupuncture during cycles 1, 3, and 5; or Group B, during cycles 2, 4, and 6, with the study oncologist blinded regarding allocation. Acupuncture will be administered on the first day (d1) and the 8th day (d8) of the chemotherapy cycles, with press-tack needles on d1 to d8, and patients will be taught to self-treat with acupressure from d8 to the next cycle. The incidence and duration of hospitalization due to CIFN will be examined, as will adherence to the chemotherapy regimen; G-CSF-related pain; and other outcomes using 3 quality-of-life-focused questionnaires. The study findings will have important implications regarding the role of acupuncture in the treatment of patients treated with chemotherapy drugs with a high risk for CIFN, such as those used in the treatment of sarcoma.",[25,86,87,88],"Sarcoma","Doxorubicin Adverse Reaction","Hospitalization-Associated Infection",[27,90,91,92,93],"acupuncture","sarcoma","doxorubicin","hospitalization","NOT_YET_RECRUITING","2026-04-23",{"date":97,"type":38},"2026-04-29",{"date":99,"type":20},"2026-12-01",{"date":101,"type":20},"2028-12-31",{"name":103,"class":45},"Shaare Zedek Medical Center",{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":16,"minAge":112,"maxAge":113,"enrollmentInfo":114,"targetDuration":4,"studyType":57,"phases":115,"briefSummary":116,"conditions":117,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":4},"100569670","impact-of-a-telemonitoring-device-on-the-occurever-at-home-in-children-at-risk-of-chemotherapy-induced-neutropenia-100569670","NCT06697262","Impact of a Telemonitoring Device on the Occurever at Home in Children at Risk of Chemotherapy-Induced Neutropenia","Impact of a Telemonitoring Device on the Occurrence of Fever at Home in Children at Risk of Chemotherapy-Induced Neutropenia: A Pilot Randomized Controlled Trial","TELEDOM","Inclusion Criteria:\n\npatient\n\n* Aged 0 to 17 inclusive\n* Followed in the Pediatric Onco-Hematology Department\n* Primo-diagnosed with solid or hematological cancer (incident case)\n* Having received a first cycle of chemotherapy\n* Whose family has psycho-social vulnerabilities assessed by the Froger et al. tool, indicating a need for an IDE to support the family in monitoring the patient.\n\nExclusion Criteria:\n\nPatient:\n\n* with a dermatosis contraindicating the use of the device\n* Refusing to participate in the study","0 Years","17 Years",{"count":56,"type":20},[59],"The goal of this clinical trial is to evaluate the feasibility of the study, measured by the acceptability rate of patients to be recruited in a study proposing temperature monitoring at home, by a remote monitoring device or by the visit of an IDE at home (in association with the usual educational sessions), to children at risk of febrile neutropenia, from families with psycho-social vulnerabilities.\n\nThe main questions it aims to answer are:\n\n* Will participants adhere to the telemonitoring system?\n* Is the intervention feasible, in terms of the device's failure to record temperature data?\n* Will parents behave appropriately when using the device?\n* How satisfied will parents and caregivers be?\n* What will be the physical tolerance of the device?\n* On an exploratory basis, will the remote monitoring system be effective for months?\n\nResearchers will compare :\n\n* patients using the telemonitoring device for continuous temperature monitoring at home, in combination with education sessions on temperature monitoring and the device\n* with patient with temperature monitoring at home by a nurse, 2 times a day, in combination with education sessions on temperature monitoring (without the telemonitoring device at home)",[118,25],"Oncopediatrics","2026-01-16",{"date":121,"type":38},"2026-01-20",{"date":123,"type":20},"2026-05-01",{"date":125,"type":20},"2028-05-04",{"name":127,"class":45},"Centre Hospitalier Universitaire de la Réunion",{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":4,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":135,"enrollmentInfo":136,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":138,"conditions":139,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":73},"100608666","efficacy-of-empirical-anti-infective-therapy-in-neutropenic-febrile-patients-100608666","NCT07204522","Efficacy of Empirical Anti-Infective Therapy in Neutropenic Febrile Patients.","Observational Study on the Efficacy of Empirical Antimicrobial Therapy in Febrile Neutropenia.","Inclusion Criteria:\n\n* Age 18-75 years.\n* Documented haematological malignancy: acute leukaemia, severe aplastic anaemia, lymphoma, or multiple myeloma.\n* Neutropenia: absolute neutrophil count (ANC) \\\u003C 0.5 × 10⁹\u002FL, or ANC anticipated to fall below this threshold within 48 h; severe neutropenia defined as ANC \\\u003C 0.1 × 10⁹\u002FL.\n* Fever: single oral temperature ≥ 38.3 °C (axillary ≥ 38.0 °C), or oral temperature ≥ 38.0 °C (axillary ≥ 37.7 °C) sustained for \\> 1 h.\n* Eastern Cooperative Oncology Group performance status (ECOG-PS) 0-2.\n* Planned or current empirical use of ceftazidime-avibactam (CAZ-AVI) for febrile neutropenia.\n\nExclusion Criteria:\n\n* Drug-related fever or fever attributable to rheumatic\u002Fautoimmune disease.\n* Concomitant intracranial haemorrhage.\n* Pregnancy, lactation, or intention to become pregnant.\n* Psychiatric disorder or any condition precluding protocol compliance.\n* Life-threatening arrhythmia or QTc \\> 500 ms on electrocardiography.","75 Years",{"count":137,"type":20},20,"This single-arm, open-label clinical study evaluates the efficacy and safety of a standardized empirical anti-infective escalation protocol for patients with hematological malignancies complicated by febrile neutropenia. The treatment algorithm follows a sequential strategy: initial carbapenem monotherapy (2 days) → if ineffective, combination with vancomycin\u002Flinezolid (3 days) → if no response, escalation to antifungal therapy (7 days). For patients demonstrating persistent or recurrent fever with uncontrolled infection parameters after 12-14 days of prior empirical anti-infective therapy, switching to ceftazidime-avibactam combined with aztreonam is implemented. Therapeutic efficacy is assessed through comprehensive evaluation of clinical manifestations, inflammatory biomarkers, radiographic imaging, and microbiological findings. Comprehensive safety surveillance includes continuous monitoring of adverse events and all-cause mortality throughout the treatment course.",[25],"2025-09-24",{"date":142,"type":38},"2025-10-02",{"date":144,"type":20},"2025-09-22",{"date":146,"type":20},"2027-09-22",{"name":148,"class":45},"Shanxi Bethune Hospital",{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":153,"acronym":154,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":156,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":158,"conditions":159,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":169},"100501928","next-generation-sequencing-approach-to-neutropenic-sepsis-100501928","NCT05815628","Next-Generation-Sequencing Approach to Neutropenic Sepsis","NEXUS","Inclusion Criteria:\n\n* Age ≥18 years\n* Informed consent\n* Neutropenia defined as \\\u003C500 ANC (Absolute neutrophil Count)\u002Fµl or \\\u003C1000 WBC (White bloddcell Count)\u002Fµl if ANC is not available\n* Fever (with an onset \\\u003C 24h) or Sepsis (with an onset \\\u003C24h) Patients with a life-threatening - organ dysfunction caused by a dysregulated host response to a suspected or proven infection.\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* Refusal or inability to give consent Inability to give informed consent if no acceptable patient representative is available\n* Patients who had previously been included, but develop a new episode of fever during the same hospitalization, will not be included a second time\n* Death is deemed imminent and inevitable",{"count":157,"type":20},400,"The aim of this prospective, observational, non-interventional, multi-centre study of the diagnostic use of DISQVER in neutropenic patients with FN is to provide further evidence of the efficacy of an NGS-based approach for detecting bloodstream infection in neutropenic patients.",[25],"2025-08-07",{"date":162,"type":38},"2025-08-08",{"date":164,"type":38},"2024-06-05",{"date":166,"type":20},"2026-11-01",{"name":168,"class":45},"Boris Böll",6,{"id":171,"slug":172,"hasResults":11,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":176,"eligibilityCriteria":177,"healthyVolunteers":11,"sex":16,"minAge":178,"maxAge":179,"enrollmentInfo":180,"targetDuration":4,"studyType":57,"phases":182,"briefSummary":184,"conditions":185,"keywords":190,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":4},"100592084","phase-4-comparison-of-g-csf--antibiotics-versus-antibiotics-alone-in-resolution-of-febrile-neutropenia-100592084","NCT06988826","Comparison of G-CSF & Antibiotics Versus Antibiotics Alone in Resolution of Febrile Neutropenia","Comparison of Antibiotics With and Without Granulocyte Colony-Stimulating Factor in Children With Chemotherapy Induced Febrile Neutropenia","AGF-FN","Inclusion Criteria:\n\n* Age 1-16 years\n* any Gender\n* Febrile neutropenia\n* diagnosed case of solid or hematological malignancy\n* taking chemotherapy\n\nExclusion Criteria:\n\n* Non-neutropenic fever\n* already received G-CSF or antibiotics before presenting to hospital\n* any other cause of neutropenia","1 Year","16 Years",{"count":181,"type":20},150,[183],"PHASE4","This study aim to find the best option for children having cancer who develop low immunity state due to chemotherapy",[25,186,187,188,189],"Febrile Neutropenia, Rule of Clinical Decision, Chemotherapy","Febrile Neutropenia, Drug-Induced","G-CSF","Antibiotic Therapy",[27,191,192,188],"chemotherapy-induced febrile neutropenia","Antibiotics","2025-05-23",{"date":195,"type":38},"2025-05-25",{"date":197,"type":20},"2025-06-01",{"date":199,"type":20},"2026-12",{"name":201,"class":45},"King Edward Medical University",{"id":203,"slug":204,"hasResults":11,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":208,"eligibilityCriteria":209,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":210,"targetDuration":4,"studyType":57,"phases":212,"briefSummary":213,"conditions":214,"keywords":215,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":225,"locationsCount":73},"100542380","phase-4-ceftolozanetazobactam-versus-meropenem-for-febrile-neutropenia-on-patients-colonized-with-or-at-risk-for-infection-with-extended-spectrum-beta-lactamase---producing-pathogens-100542380","NCT06342115","Ceftolozane\u002FTazobactam Versus Meropenem for Febrile Neutropenia on Patients Colonized With or at Risk for Infection With Extended Spectrum Beta Lactamase - Producing Pathogens","Ceftolozane\u002FTazobactam Versus Meropenem for Febrile Neutropenia on Patients Colonized With or at Risk for Infection With Extended Spectrum Beta Lactamase (ESBL)-Producing Pathogens: a Randomized Double-blind Non-inferiority Trial.","CLEMENT","Inclusion criteria:\n\n\\- Individuals who present with the onset of febrile neutropenia and at the same time present colonization with an ESBL-producing pathogen (identified through positive routine rectal swabs and\u002For positive culture of clinical specimen) or risk of infection with an ESBL-producing pathogen (use of 3rd\u002F4th gen cephalosporin or piperacillin\u002Ftazobactam for at least 48 hours in the last 30 days).\n\nExclusion Criteria:\n\n* Patients known to be colonized with carbapenem-resistant or CEF\u002FTAZ-resistant pathogens\n* Patients with previous use of carbapenems for at least 48h in the past 30 days are also excluded due to risk of resistance to the study drugs.\n* Growth of a pathogen resistant to either study drug in a relevant clinical specimen during the intervention phase will be followed by adjustment of therapy according to local protocol, unblinding, and exclusion from the study.\n* Patients that have received less than 72h of either study drug will also be excluded from the final analyses.",{"count":211,"type":20},176,[183],"The study proposes a planned, double-blind, non-inferiority clinical trial involving patients with febrile neutropenia and risk of extended-spectrum beta-lactamase (ESBL) infection. The goal is:\n\n\\- Analyze the efficacy and tolerability of Ceftolozane\u002Ftazobactam (CEF\u002FTAZ) compared to the current standard of care (meropenem) in patients with febrile neutropenia and risk of ESBL infection.\n\nPatients will be randomly assigned to receive CEF\u002FTAZ or meropenem, with assessment of clinical response, toxicity and microbiological evolution. Stool samples will be collected before, during and after treatment for intestinal microbiota analysis and intestinal microbiome analysis to evaluate possible effects on GVHD. Analysis of the results will include the taxonomic classification of the organisms present. Data will be analyzed to assess non-inferiority in clinical response, incidence of GVHD, antimicrobial resistance and other outcomes.",[25],[25,216,217,218],"Ceftolozane\u002Ftazobactam","ESBL","Meropenem","2025-04-30",{"date":221,"type":38},"2025-05-02",{"date":223,"type":38},"2025-03-26",{"date":199,"type":20},{"name":226,"class":45},"Beneficência Portuguesa de São Paulo",{"id":228,"slug":229,"hasResults":11,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":4,"eligibilityCriteria":233,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":234,"targetDuration":4,"studyType":57,"phases":236,"briefSummary":237,"conditions":238,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":248},"100499687","short-antibiotic-treatment-in-high-risk-febrile-neutropenia-100499687","NCT05786495","Short Antibiotic Treatment in High Risk Febrile Neutropenia","Early Discontinuation of Antibiotics for Unexplained Febrile Neutropenia: a Pilot Randomized Controlled Trial- EASE ANTIBIOTICS Pilot Trial","Inclusion Criteria:\n\n1. Age 18 years and older.\n2. The patient either has acute leukemia (AML, ALL or mixed-phenotypic acute leukemia) and is undergoing induction, re-induction or salvage chemotherapy or undergoing allogeneic HSCT and receiving conditioning chemotherapy and\u002For radiation.\n3. Documented febrile neutropenia as defined by the IDSA guidelines \\[1\\]:\n\n   1. Single oral temperature of ≥38.3°C or at least two measurements of ≥38.0°C in an interval of ≥1 hour.\n   2. ANC ≤ 0.5x109\u002FL.\n4. Patient without a clinically or microbiologically documented infection (CDI\u002FMDI).\n\n   We will require the following criteria to rule out infection:\n   1. No focus of infection on a thorough history and physical examination at baseline and daily.\n   2. Negative blood cultures after at least two sets of blood cultures have been taken. For example, the growth of coagulase-negative staphylococci, diphtheroids or Bacillus spp. from a single set will be considered contamination if another set of blood cultures is negative. Therefore, additional blood cultures will be taken in this case.\n   3. Other cultures will be taken as indicated.\n   4. A negative chest XR or CT scan (which will be performed according to the physician's discretion) for patients with symptoms of cough or chest pain.\n5. The subject will comply with the following criteria:\n\n   1. Received empirical antibiotics for at least 72 hours AND\n   2. Is afebrile for at least 24 hours AND\n   3. Is still neutropenic (ANC ≤0.5x109\u002FL).\n\nExclusion Criteria:\n\n1. Concurrent participation in another interventional trial.\n2. The patient has received empirical antibiotics for more than seven days from the onset of the febrile neutropenic episode.\n3. Septic shock at the onset of the episode or 72 hours (defined as persisting hypotension requiring vasopressors to maintain a MAP ≥ 65 mmHg and having a serum lactate level \\> 2 mmol\u002FL despite adequate volume resuscitation).\n4. Patients with febrile neutropenia secondary to the treatment for solid malignancies, autologous HSCT, CAR-T cell therapy, hematologic malignancies besides acute leukemia when not in the context of allogeneic HSCT, AML treated with consolidation chemotherapy, or ALL treated with intensification and maintenance phase of chemotherapy.\n5. Clinically or microbiologically documented infections except for probable or proven invasive fungal disease diagnosed a-priori and treated.\n6. Patients receiving their induction chemotherapy or allogeneic HSCT as outpatients.\n7. We will not allow the enrollment of patients who have been previously enrolled in this study.",{"count":235,"type":20},80,[59],"Infections are a common complication in patients with cancer. They are a significant cause of complications and death in this population. Patients with cancer and low neutrophil counts due to chemotherapy or disease often have a fever and receive antibiotic treatment. The optimal duration of this treatment is largely unknown. Late, there have been some data suggesting the safety of early discontinuation of antibiotics, though most centers still give more prolonged antibiotic therapies in this situation. The unnecessary prolonged antibiotic use may increase infections with multi-drug-resistant bacteria, which carry a high death rate. Also, an increase in infections caused by Clostridioides difficile and an increase in fungal infections can happen. However, some are concerned that stopping antibiotics while the neutrophil count is still low will result in life-threatening infections. Our study aims to test whether shorter antibiotic treatment in these situations is as safe as more prolonged treatment, resulting in better antibiotic prescription practices in this population.",[25],"2024-07-15",{"date":241,"type":38},"2024-07-17",{"date":243,"type":38},"2023-10-01",{"date":245,"type":20},"2026-02-28",{"name":247,"class":45},"University Health Network, Toronto",4,{"id":250,"slug":251,"hasResults":11,"nctId":252,"briefTitle":253,"officialTitle":254,"acronym":255,"eligibilityCriteria":256,"healthyVolunteers":11,"sex":16,"minAge":257,"maxAge":17,"enrollmentInfo":258,"targetDuration":4,"studyType":57,"phases":259,"briefSummary":260,"conditions":261,"keywords":262,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":73},"100538656","phase-4-adjustment-of-antibiotic-dosage-in-pediatric-oncology-patients-with-febrile-neutropenia-and-augmented-renal-clearance-100538656","NCT06293677","Adjustment of Antibiotic Dosage in Pediatric Oncology Patients With Febrile Neutropenia and Augmented Renal Clearance","Upwards Initial Adjustment of Wide-Spectrum Antibiotic Dosage in Pediatric Oncology Patients With Febrile Neutropenia and Suspected Augmented Renal Clearance: A Randomized Controlled Trial With Therapeutic Drug Monitoring","DAR-ARC","Patients' inclusion criteria\n\n* Oncologic patients aged 2 months to 17 years (older than 60 days and younger than 18 years),\n* High probability of febrile neutropenia during the study period\n* Written informed consent from parents and adolescents older than 14 years\n\nPatients' exclusion criteria\n\n* Neutropenia not related to cancer and\u002For chemotherapy\n* Refusal to participate\n* Non-French speaking parents\u002Fpatients older than 11 years old\n* Absence of febrile neutropenia or agranulocytosis during the study period (secondary exclusion)\n\nFebrile neutropenia episodes inclusion criteria\n\n* Febrile neutropenia or agranulocytosis defined as:\n\n  * Neutropenia: absolute neutrophils \\<500 cells\u002FµL or agranulocytosis: absolute neutrophils \\<100 cells\u002FµL or patients expected to be neutropenic in the next 24 hours due to ongoing chemotherapy\n  * body temperature (tympanic or axillary) ≥38°C during at least one hour or a single T ≥38.5°C\n* At least 2 weeks after the end of the previous antibiotic treatment for another included episode of febrile neutropenia.\n\nFebrile neutropenia episodes exclusion criteria:\n\n* Severe renal failure (GFR\\<15 mL\u002Fmin\u002F1.73 m²)\n* Pregnancy\n* Inability to obtain the first therapeutic drug monitoring (TDM) result within 72 hours of sampling (e.g. admission before or during public holidays laboratory closure)","61 Days",{"count":56,"type":20},[183],"This clinical trial focuses on children with cancer who face infections after receiving chemotherapy. Chemotherapy affects the bone marrow, leading to a decrease in the production of certain white blood cells, particularly those that defend against bacterial infections (neutrophils). One significant concern is febrile neutropenia, where children experience a fever during a period of low white blood cell count. This condition often results from bacterial infections, necessitating prompt wide-spectrum antibiotic treatment. However, some children eliminate antibiotics in the urine too quickly during febrile neutropenia. Their kidneys function more than they normally do (renal hyperfiltration). This can lead to insufficient exposure to antibiotics to control the infection. The current standard antibiotic regimens do not account for this variable elimination rate. In this study we focus on two antibiotics used in this context: piperacillin-tazobactam and meropenem.\n\nThe main questions this study aims to answer are, in these children:\n\n* Would higher doses of antibiotics result in better blood levels of antibiotics?\n* Would they have more sides effects with higher antibiotics dosages?\n* Would they recover more quickly with higher antibiotic doses? All patients will undergo a blood test upon hospital arrival, including an assessment of renal function. If renal function is normal or diminished, the patient will receive the standard antibiotic dose. Children with increased renal function will be randomly assigned to two groups during each episode of febrile neutropenia. One group will receive standard antibiotic dosages, while the other will receive higher doses to compensate for renal hyperfiltration. Throughout the study, antibiotic levels in the blood will be monitored for all patients. This monitoring will determine if target concentrations can be achieved more quickly with experimental dosages and will allow doctors to readjust the doses if needed.",[25],[263,264,265,266,267,268,269],"Febrile neutropenia","Augmented Renal Clearance","Pediatric cancer","Therapeutic Drug monitoring TDM","Children","Wilde-spectrum antibiotic dosage","Glomerular filtration rate GFR","2024-07-10",{"date":272,"type":38},"2024-07-11",{"date":274,"type":38},"2024-03-01",{"date":276,"type":20},"2026-03",{"name":278,"class":45},"Centre Hospitalier Universitaire Vaudois",{"id":280,"slug":281,"hasResults":11,"nctId":282,"briefTitle":283,"officialTitle":284,"acronym":4,"eligibilityCriteria":285,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":286,"targetDuration":4,"studyType":57,"phases":287,"briefSummary":288,"conditions":289,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":295,"startDateStruct":297,"completionDateStruct":299,"leadSponsor":300,"locationsCount":73},"100550726","prospect-prior-2-chemo-prior-dental-intervention-before-chemo-to-reduce-chemotherapy-complications-100550726","NCT06450821","PROSpECT-PRIOR-2-CHEMO: PRIOR Dental Intervention Before Chemo to Reduce Chemotherapy Complications","PROSpECT-PRIOR-2-CHEMO: A Feasibility RCT of Novel Dental Intervention PRIOR[Proactive Intensive Oral Review & Treatment] in Patients Scheduled for Chemotherapy for Myeloma-ASCT & Hematological Cancers to Mitigate Chemotherapy Complications","Inclusion Criteria (mod-high\u002Frisk trial participants):\n\n* Adults (≥ 18years) with scheduled Chemotherapy. Specifically, patients who meet the following diagnosis and treatment window requirements:\n\n  * Myeloma- Autologous Stem Cell Transplantation (ASCT) before high-dose myeloablative CT.\n  * Haematological cancers suitable for Allografts Stem Cell Transplant (SCT) before CT\n* Moderate \u002F High Oral Health Risk Assessment - any one of the following:\n\n  * Clinical evidence of caries (2+ teeth)\n  * Clinical evidence on soft and hard tissue examination of infection, sinus, swelling or tenderness\n  * BPE code 3-4 in any remaining sextant\n  * BPE code 1-2 with \\>30% BOP\n* The patient is fully informed, has received PIS (patient information sheet) and considered during a 'cooling-off' period, is competent to consent, and is able to comply with minimum attendance requirements\n\nExclusion Criteria:\n\n* Have a history of head and neck radiotherapy\n* Have been treated with Denusomab, Bevacizumab, Sunitinib or Aflibercept within 9 months of the MDT date.\n* Insufficient teeth \\[defined as \\\u003C2\\]\n* Are incapable of providing informed written consent\n* Are unable to comply with minimum attendance requirements",{"count":82,"type":20},[59],"The aim of this feasibility trial is to determine if it is safe and feasible to treat oral health diseases in people with haematological cancers before they start their chemotherapy to reduce complications and disruption to planned chemotherapy dose or schedule.",[290,291,292,293,25],"Oncology","Periodontitis","Myeloma","Oral Mucositis","2024-06-04",{"date":296,"type":38},"2024-06-10",{"date":298,"type":20},"2024-07",{"date":70,"type":20},{"name":301,"class":45},"University of Leeds",{"id":303,"slug":304,"hasResults":11,"nctId":305,"briefTitle":306,"officialTitle":307,"acronym":308,"eligibilityCriteria":309,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":310,"targetDuration":4,"studyType":57,"phases":312,"briefSummary":314,"conditions":315,"keywords":318,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":320,"startDateStruct":322,"completionDateStruct":323,"leadSponsor":325,"locationsCount":4},"100537520","phase-3-early-neutropenic-fever-de-escalation-of-antibiotics-study-100537520","NCT06278896","Early Neutropenic Fever De-escalation of Antibiotics Study","Early Neutropenic Fever De-escalation (END) of Antibiotics Study","END","Inclusion Criteria:\n\n1. Participant or healthcare proxy with the ability to understand and willingness to sign an informed consent.\n2. Adults \\>18 years old.\n3. Likely to have neutropenia \\> 7 days including such conditions as: acute leukemia; lymphoproliferative disease; multiple myeloma; myelodysplastic syndrome; bone marrow aplasia and autologous or allogeneic hematopoietic stem cell transplantation. Neutropenia defined as absolute neutrophil count \\\u003C500.\n4. Received or planned to receive cytotoxic chemotherapy. No restrictions on prior therapy regarding dose or agent.\n5. High-risk neutropenia defined as expected duration of absolute neutrophil count less than 500 cells\u002FµL for seven or more days.\n6. Admitted as an inpatient at Mass General Brigham or Dana Farber Cancer Institute (DFCI).\n7. Initial fever (defined as a single oral temperature of ≥38.3°C or a temperature of ≥38.0°C sustained over a one-hour period) during hospital admission or as reason for admission.\n8. Has been afebrile for 48 hours.\n\nExclusion Criteria:\n\n1. Microbiologically or clinically suspected bacterial infection after index fever.\n2. Exposure to treatment antibacterial therapy 72 hours before first fever occurrence other than antibiotics deemed as prophylaxis.",{"count":311,"type":20},260,[313],"PHASE3","This is a randomized, open label clinical trial among individuals with hematologic conditions. The trial aims to evaluate the safety and clinical outcomes of de-escalating antibiotic therapy among stable individuals diagnosed with neutropenic fever, in which no bacterial infection has been identified.",[316,25,317],"Hematologic Malignancy","Antibiotic Stewardship",[25],"2024-02-23",{"date":321,"type":38},"2024-02-26",{"date":274,"type":20},{"date":324,"type":20},"2028-03-01",{"name":326,"class":45},"Brigham and Women's Hospital"]