[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"febrile-neutropenia-fn\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:febrile-neutropenia-fn":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,48,79,116],{"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":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100648814","phase-2-phase-ii-study-of-qlc2519-in-pediatric-solid-tumor-participants-100648814",false,"NCT07724756","Phase II Study of QLC2519 in Pediatric Solid Tumor Participants","A Multicenter, Open-label Phase II Clinical Study Evaluating the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of Albipagrastim Alfa for Injection (QLC2519) in Pediatric Solid Tumor Participants","Inclusion Criteria:\n\n* Age 0-18 years (excluding boundary values), any gender;\n* Participant diagnosed with pediatric sarcoma based on pathological histology;\n* Participant was suitable for receiving the VDC\u002FIE chemotherapy regimen, and planning to receive at least 3 chemotherapy cycles (VDC: vincristine, doxorubicin, cyclophosphamide; IE: ifosfamide, etoposide);\n* ECOG ≤1;\n* Expected survival ≥3 months, and expected to complete the 3 chemotherapy cycles specified in the regimen;\n* Hematology, liver function, and renal function before the first administration of chemotherapy drugs meet the following requirements:\n* Hematology: absolute neutrophil count (ANC) in peripheral blood ≥2.0×10\\^9\u002FL (or above the lower limit of normal); platelet count (PLT) ≥100×10\\^9\u002FL; hemoglobin (HGB) ≥90 g\u002FL; white blood cell count (WBC) ≥4.0×10\\^9\u002FL;\n* Liver function: total bilirubin (TBIL) ≤1.5×ULN, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5×ULN; for patients with liver metastasis, ALT and AST ≤2.5×ULN;\n* Renal function: serum creatinine (Cr) ≤1.5×ULN or creatinine clearance rate (CCr) ≥60 mL\u002Fmin;\n* Normal bone marrow hematopoietic function, no bleeding tendency (INR \\\u003C1.5);\n* Female participants of potential reproductive ability (post-menarche) are neither pregnant nor breastfeeding; participants of potential reproductive ability (e.g., females post-menarche or males post-spermarche) must agree to use effective contraception from the time of signing the informed consent until at least 3 months after the last administration.\n\nExclusion Criteria:\n\n* Tumor had metastasized to or invaded the bone marrow;\n* Previously received chemotherapy or radiotherapy;\n* Planned surgery or radiotherapy during the trial (excluding the follow-up period);\n* Presence of other malignant tumors besides sarcoma (participants with previously cured malignant tumors with no recurrence within the past 5 years may be included in this study);\n* Primary central nervous system tumor or existing central nervous system involvement, or suspected central nervous system metastasis based on clinical manifestations, deemed unsuitable for participation in this study by the investigator;\n* History of primary hematologic diseases, including but not limited to leukemia, myelodysplastic syndromes, aplastic anemia, sickle cell anemia, congenital neutropenia, or cyclic neutropenia;\n* Previously received or planned to undergo bone marrow transplantation, hematopoietic stem cell transplantation, or organ transplantation during the trial;\n* Diseases with severe cardiac dysfunction, including but not limited to poorly controlled arrhythmia or heart failure;\n* Diseases with severe pulmonary dysfunction, including but not limited to pulmonary embolism, lung abscess, or acute respiratory distress syndrome;\n* Presence of splenomegaly or diseases that may cause splenomegaly (such as liver cirrhosis, Gaucher disease, glycogen storage disease, Niemann-Pick disease, etc.), considered unsuitable for participation in this study by the investigator;\n* Presence of acute infectious disease or chronic infectious disease in the active phase at screening, such as hepatitis B patients who are hepatitis B surface antigen (HbsAg) positive with detectable HBV-DNA indicating viral replication, hepatitis C patients who are anti-HCV antibody positive with detectable HCV-RNA indicating viral replication; positive syphilis screening (positive specific antibody test, negative nonspecific antibody test, and confirmed as non-active infection based on clinical judgment is excluded);\n* History of human immunodeficiency virus (HIV) infection, or HIV positive at screening;\n* Undergoing major surgery within 1 month prior to screening (high-risk, complex, or difficult procedures, such as thoracoscopic pulmonary bulla resection or thoracoscopic esophageal atresia surgery);\n* Received or planned to use recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) within 1 week prior to screening or during the trial;\n* Received glucocorticoid (oral or intravenous) or lithium treatment within 1 week prior to screening;\n* Received whole blood, white blood cells, or platelet transfusion within 2 weeks prior to screening;\n* Received human granulocyte colony-stimulating factor (G-CSF) treatment within 3 months prior to screening;\n* Received systemic anti-infective therapy (oral or intravenous) within 72 hours prior to screening;\n* History of drug or alcohol abuse, or history of substance abuse;\n* Received other clinical trial drugs or treatments within 4 weeks prior to screening;\n* History of allergic diseases, being of an allergic constitution, or known allergy to any drug or component of this trial.","ALL","0 Years","18 Years",{"count":20,"type":21},18,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","QLC2519 (Mai Li Sheng®) is a new protein drug created by fusing the N-terminal of highly active modified G-CSF with the C-terminal of HSA. The modified G-CSF retained high activity while reducing affinity for the G-CSF receptor, which can significantly inhibit the the G-CSF receptor-mediated (RMC) pathway. The aim of this study is to evaluate the PK\u002FPD characteristics of QLC2519 in preventing chemotherapy-induced neutropenia (CIN) in children with sarcoma.",[27,28,29],"Pediatric Malignant Solid Tumor","Febrile Neutropenia (FN)","Neutropenia",[27,31,32,33,34],"Children","Albipagrastim alfa for Injection","neutropenia","Febrile neutropenia (FN)","RECRUITING","2026-07-20",{"date":38,"type":39},"2026-07-24","ACTUAL",{"date":41,"type":21},"2026-06-26",{"date":43,"type":21},"2028-06-26",{"name":45,"class":46},"Qilu Pharmaceutical Co., Ltd.","INDUSTRY",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":65,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":47},"100621554","antibiotic-duration-and-outcomes-in-high-risk-febrile-neutropenia-patients-100621554","NCT07372131","Antibiotic Duration and Outcomes in High-Risk Febrile Neutropenia Patients","Appropriate Management of Bacteriemic Febrile Neutropenia in High-Risk Hematological Patients. Relationship Between Duration of Antibiotic Administration, Outcome and Resistance Profile","PERaSTrA","Inclusion Criteria:\n\n* Diagnosed with a hematologic malignancy that is candidate for treatment with chemotherapy or bone marrow transplantation or chimeric antigen receptor T cell therapy (CAR-T)\n* Diagnosis of febrile neutropenia defined according to the guidelines of the Infectious Disease Society of America, IDSA; ref: Freifeld, A.G., et al., Clinical practice guideline for the use of antimicrobial agents in neutropenic patients with cancer: 2010 update by the infectious diseases society of america. Clin Infect Dis, 2011. 52(4): p. e56-93.) as: Fever: single record of oral temperature \\>=38.3°C or a temperature \\>=38.0°C sustained over a period of one hour; Neutropenia: absolute neutrophil count \\\u003C 1000 cells\u002FmicroL; Expected duration of neutropenia \\>= 7 days\n* Diagnosis of bacteraemia defined by positive blood cultures (at least 1 vial positive for a non-contaminating microorganism)\n* Isolation of Gram-Negative species\n\nExclusion Criteria:\n\n* Contextual diagnosis of pneumonia\n* Contextual diagnosis of intra-abdominal infection, in particular: neutropenic enterocolitis\u002Ftyphlitis or biliary tract infection\n* Persistently positive blood cultures at randomization\n* Any condition that endangers the safety of the patient based on the judgment of the treating physician",{"count":57,"type":21},172,[59],"NA","The goal of this clinical trial is to learn if a personalized duration of antibiotic therapy, based on clinical stability, is as effective as a standard duration of at least 10 days in hospitalized patients with hematologic malignancies (such as leukemia or lymphoma) who develop febrile neutropenia and Gram-negative bacteraemia.\n\nThe main questions it aims to answer are:\n\n* Can a personalized antibiotic duration increase the number of days free from anti-Gram-negative therapy within 28 days without compromising patient safety?\n* How does the duration of antibiotic therapy (short vs. prolonged) affect the rate and modality of gut microbiota reconstitution?\n\nResearchers will compare:\n\n* Group A (Personalized Duration): Antibiotics are stopped after the patient maintains clinical stability (no fever and stable vital signs) for 72 consecutive hours.\n* Group B (Standard of Care): Antibiotics are continued for a standard duration, typically at least 10 days, based on current clinical surveys and physician decision.\n\nParticipants will:\n\n* Be randomized to receive either the personalized or the standard duration of antibiotic therapy once a Gram-negative infection is confirmed in the blood.\n* Be monitored for 28 days to assess for new fever episodes, recurrence of infection, and overall survival.\n* If participating in the microbiological sub-study, provide biological samples (blood, feces, and rectal swabs) at specific time points (at the onset of fever, at the end of treatment, and at day 28).\n* Undergo specialized laboratory testing (Whole Metagenomic Sequencing) on the collected samples to evaluate the evolution of their intestinal and blood microbiota and the presence of antibiotic-resistant genes.",[62,63,64,28],"Bloodstream Infection","Gram Negative Infections","Bacteraemia Caused by Gram-Negative Bacteria",[66,62,67,68],"Antibiotics","Hematological patients with febrile neutropenia","Gram-negative","2026-07-14",{"date":71,"type":39},"2026-07-15",{"date":73,"type":39},"2026-01-25",{"date":75,"type":21},"2028-11-30",{"name":77,"class":78},"Valeria Cento","OTHER",{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":18,"enrollmentInfo":87,"targetDuration":4,"studyType":22,"phases":89,"briefSummary":91,"conditions":92,"keywords":97,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":5},"100639005","phase-4-early-discontinuation-of-antibiotics-in-paediatric-high-risk-febrile-neutropenia-100639005","NCT07590648","Early Discontinuation of Antibiotics in Paediatric High-risk Febrile Neutropenia","Phase IV, Randomized, Open Label, Parallel Groups Clinical Trial for Evaluating the Early Stop of Antibiotic Treatment in High-risk Febrile Neutropenic Oncohaematological Paediatric Patients (e-STOP 2)","E-STOP2","Inclusion Criteria:\n\n1. Male and female patients ≤18 years of age expected to develop prolonged neutropenia (\\>7 days), with:\n\n   * Acute myeloblastic leukaemia at any phase of chemotherapy\n   * Acute lymphoblastic leukaemia in induction, consolidation, or intensification phases\n   * Biphenotypic leukaemia at any phase of chemotherapy\n   * Lymphoblastic lymphoma in induction and consolidation phases\n   * B-cell and anaplastic lymphoma receiving high-intensity chemotherapy\n   * Solid tumours receiving high-intensity chemotherapy\n   * Relapsed leukaemia at any phase of treatment\n2. Episode of febrile neutropenia (FN), defined as a single axillary temperature ≥38.0°C in a patient with an absolute neutrophil count (ANC) \\\u003C500 neutrophils\u002Fmm³, or expected to fall below this value within the next 48-72 hours.\n3. Antibiotic treatment initiated for the current FN episode (routine antimicrobial prophylaxis is allowed, as well as teicoplanin 3 days\u002Fweek for patients with AML included in the CHIP-AML-2022 protocol and therefore in the Pro-teico study).\n4. Low risk of invasive bacterial infection (IBI) at the start of the FN episode. Patients must meet all of the following:\n\n   * CRP \\\u003C9 mg\u002FdL\n   * PCT \\\u003C0.5 ng\u002FmL\n   * Absence of hypotension\n5. No microbiologically documented bacterial infection 48-72 hours after the FN episode.\n6. Good clinical evolution 48-72 hours after the FN episode, defined as:\n\n   * Afebrile for \\>48 hours (axillary temperature \\\u003C38°C)\n   * Haemodynamically stable\n   * Stable paediatric early warning score (PEWS)\n7. CRP \\\u003C5 mg\u002FdL, or CRP \\\u003C9 mg\u002FdL and PCT \\\u003C0.5 ng\u002FmL, with decreasing trend at the time of randomisation (values will be assessed on day 3 and day 5 after the FN episode).\n8. ANC \\\u003C500 neutrophils\u002Fmm³ at the time of randomisation.\n9. Signed informed consent from the patient and\u002For parent(s)\u002Flegal representative(s).\n10. Patient and\u002For parent(s)\u002Flegal representative(s) must have sufficient reading and writing skills to understand and provide consent to participate in the study.\n11. Patient and\u002For parent(s)\u002Flegal representative(s) must be considered reliable and capable of adhering to the protocol.\n\nExclusion Criteria:\n\n1. Antibiotic treatment at the time of the FN episode different from that used prophylactically.\n2. Empirical antibiotic treatment different from that recommended in international guidelines.\n3. Patient with poor clinical evolution during the first 12 hours (hemodynamic instability, PICU admission, death).\n4. Active participation in the same study at the onset of the current FN episode.\n5. Active participation in another clinical trial that, in the investigators' opinion, may interfere with the assessment of the results.\n6. Any condition which, in the investigator's opinion, makes study participation unsuitable for the patient or could limit, prevent, or confound the assessments planned in the protocol.\n7. Female patients who are pregnant or breastfeeding",{"count":88,"type":21},136,[90],"PHASE4","The goal of this clinical trial is to evaluate whether stopping antibiotic treatment early is safe in paediatric patients with cancer who develop high-risk febrile neutropenia but show good clinical evolution and low biomarker levels 48-72 hours after the episode.\n\nThe main questions it aims to answer are:\n\nIs early discontinuation of antibiotics as safe as the standard strategy in terms of preventing invasive bacterial infections (such as sepsis, microbiologically documented infection, ICU admission, or death)? Does this strategy reduce the number of days on antibiotics without increasing infection-related complications?\n\nResearchers will compare early antibiotic discontinuation with the standard care strategy to see whether the early-stop approach provides similar safety while reducing antibiotic exposure.\n\nParticipants will:\n\nReceive standard initial antibiotic therapy for febrile neutropenia. Undergo clinical and biomarker evaluations (including CRP and PCT).\n\nBe randomly assigned to:\n\nExperimental group: early discontinuation of antibiotics, or Control group: continuation of the standard antibiotic strategy.\n\nBe followed for 28 days after randomisation to monitor safety outcomes and treatment effects.",[28,93,94,95,96],"Pediatric Cancer","Hematologic Malignancies","Solid Tumors","Invasive Bacterial Infection",[98,99,94,95,96,100,101,102,103,104,105,29],"Febrile Neutropenia","Pediatric Oncology","Antibiotic Discontinuation","Antibiotic Stewardship","Biomarkers (CRP, PCT, IL-8)","Early Stop Strategy","Randomized Clinical Trial","Non-Inferiority Trial","NOT_YET_RECRUITING","2026-05-13",{"date":109,"type":39},"2026-05-15",{"date":111,"type":21},"2026-06-01",{"date":113,"type":21},"2028-07-01",{"name":115,"class":78},"Hospital Universitari Vall d'Hebron Research Institute",{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":16,"minAge":18,"maxAge":4,"enrollmentInfo":124,"targetDuration":4,"studyType":22,"phases":126,"briefSummary":127,"conditions":128,"keywords":132,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":146},"100567249","phase-4-outcomes-of-early-and-late-administration-g-csf-for-primary-prophylaxis-in-non-hodgkins-lymphoma-patients-100567249","NCT06665737","Outcomes of Early and Late Administration G-CSF for Primary Prophylaxis in Non-Hodgkin's Lymphoma Patients","A Comparison Outcomes of Early and Late Administration G-CSF for Primary Prophylaxis in Non-Hodgkin's Lymphoma Patients Who Receive Chemotherapy, Multicenter Study","G-CSF in NHL","Inclusion Criteria:\n\n* Aged 18 years or old\n* Confirmed lymphoma undergoing standard chemotherapy\n* Signed an approval informed consent\n* Has a good understanding of Thai\n* Available for follow-up after chemotherapy\n\nExclusion Criteria:\n\n* Pregnancy or lactation\n* Serious concomitant diseases and discontinuous treatment such as cardiovascular, liver, or kidney diseases\n* Contraindication to chemotherapy or G-CSF administration\n* Antibiotic use within 1 week prior to enrollment",{"count":125,"type":21},126,[90],"The goal of this clinical trial is to\n\nPrimary Objectives:\n\n1. To compare the incidence of febrile neutropenia in patients with non-Hodgkin's lymphoma who received early or late granulocyte colony-stimulating factor (G-CSF) during standard chemotherapy in a multicenter study\n2. To determine the incidence of leukopenia and neutropenia in patients with non-Hodgkin's lymphoma who received early or late G-CSF during standard chemotherapy in a multicenter study\n\nSecondary Objectives:\n\n1. To determine changes in white blood cell, hemoglobin, and platelet levels in patients with non-Hodgkin's lymphoma who received early or late G-CSF during standard chemotherapy.\n2. To determine the quality of life of patients with non-Hodgkin's lymphoma who undergoing standard chemotherapy and with neutropenia Researchers will compare the outcome between patients received either early G-CSF (within 72 hours) or late G-CSF (after 72 hours).\n\nAll patients will be followed up to monitor for febrile neutropenia events, other hematological parameters and quality of life.",[129,130,28,131],"Non-Hodgkin's Lymphoma (NHL)","Granulocyte Colony Stimulating Factor","Myelosuppression Adult",[133,134,130,135],"Non-Hodgkin's lymphoma","Febrile neutropenia","Myelosuppression","2025-01-24",{"date":138,"type":39},"2025-01-28",{"date":140,"type":21},"2025-02-01",{"date":142,"type":21},"2026-12-31",{"name":144,"class":145},"Department of Medical Services Ministry of Public Health of Thailand","OTHER_GOV",3]