[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"dengue-fever-with-warning-signs\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:dengue-fever-with-warning-signs":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,76],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":4},"100647981","phase-3-phase-3b-trial-to-evaluate-safety-and-immune-response-superiority-of-a-two-dose-butantan-dv-regimen-and-the-standard-single-dose-in-dengue-naive-childrenadolescents-and-immune-response-non-inferiority-in-a-manufacturing-facility-change-den-06-ib-100647981",false,"NCT07712926","Phase 3b Trial To Evaluate Safety And Immune Response (Superiority) of a Two-Dose Butantan-DV Regimen And The Standard Single Dose In Dengue-Naive Children\u002FAdolescents and Immune Response (Non-inferiority) in a Manufacturing Facility Change (DEN-06-IB)","A Multicenter, Randomized, Controlled, Parallel-Group, Phase 3b Clinical Trial To Evaluate The Immunological Superiority Of The Two-Dose Butantan-Dv Regimen-Administered With A 9-Month Interval-Compared To The Single-Dose Regimen, And The Immunological Non-Inferiority Following A Change In Manufacturing Facility, In Children And Adolescents With No Prior Dengue Exposure.","DEN-06-IB","Inclusion Criteria:\n\n1. Participants aged 2 to 17 years at the time of study enrollment with no prior dengue exposure (as determined by IgG ELISA), at research centers located in cities within areas of low to medium endemicity for dengue virus infection.\n2. Agreement to periodic contact via telephone, electronic means, and home or research center visits.\n3. Participants of reproductive potential must be using an effective contraceptive method for at least 30 days at screening and continue doing so until Day 363 post-first vaccination; exceptions apply if the participant (or their legal representative) declares the participant to be at no risk of pregnancy-whether due to sexual abstinence or engaging in non-reproductive sexual practices-through Day 363 post-first vaccination.\n4. Demonstrated intention to participate in the study, documented by the signature of the informed consent form by the participant's parents and the informed assent form by the participant (where applicable), as well as agreement to study procedures, including completing participant diaries, undergoing blood sampling, and being available for scheduled study visits and contacts.\n\nExclusion Criteria:\n\n1. Reactive or unavailable dengue IgG ELISA test result.\n2. For female participants of reproductive potential: pregnancy (confirmed by a positive β-hCG test), breastfeeding, or expressed intention to engage in sexual practices with reproductive potential without using a contraceptive method up to Day 363 after the first vaccination;\n3. Planned donation of blood, semen, or ova up to Day 363 after the first vaccination;\n4. Evidence of active, uncontrolled neurological, cardiac, pulmonary, hepatic, or renal disease-defined as disease requiring a change in treatment or hospitalization due to worsening of the condition within the 90 days prior to study screening, based on medical history or physical examination, at the investigator's judgement;\n5. Diseases compromising the immune system, including: decompensated diabetes mellitus; active neoplasms or a history of neoplasms within the last five years (except basal cell carcinoma); congenital or acquired immunodeficiencies (except HIV infection with undetectable viral load and CD4+ T-lymphocyte count \\> 500 cells\u002Fmm³); solid organ transplantation (heart, liver, pancreas, lung, kidney); or uncontrolled autoimmune diseases (based on medical history or physical examination); as well as a history of hepatic insufficiency, heart failure, or end-stage or dialysis-dependent chronic kidney disease;\n6. Behavioral, cognitive, or psychiatric condition that, in the opinion of the principal investigator or their medical representative, affects the potential participant's ability to understand and comply with the study protocol requirements;\n7. Any use of alcohol or drugs considered abusive within the 12 months prior to study enrollment that has caused medical, occupational, or family problems, as indicated by clinical history;\n8. History of severe allergic reaction or anaphylaxis to the study vaccine or its components;\n9. History of asplenia;\n10. Participation in another clinical trial involving the administration of an investigational product during the six months prior to study enrollment, or participation in another clinical trial during the 12 months following enrollment;\n11. Prior participation in a clinical study of (or exposure to) any dengue vaccine;\n12. Use of potent immunosuppressive therapies (excluding corticosteroids) in the six months prior to study enrollment. Potent immunosuppressive therapies are considered to include: antineoplastic chemotherapy, radiotherapy, immunosuppressants used to induce transplant tolerance, and potent monoclonal antibody therapy for the treatment of rheumatological diseases, among others;\n13. Receipt of an immunosuppressive dose of corticosteroids within the three months prior to study enrollment. An immunosuppressive corticosteroid dose is defined as equivalent to a prednisone dose of 2 mg\u002Fkg\u002Fday for children and 20 mg\u002Fday for adolescents for 14 days (a cumulative equivalent dose of at least 280 mg of prednisone). Continuous use of topical or nasal corticosteroids is not considered immunosuppressive;\n14. Receipt of blood components (transfusions) or blood derivatives (immunoglobulins) within the six months prior to study enrollment;\n15. Any other condition that, in the opinion of the principal investigator or their medical representative, could jeopardize the safety or rights of a potential participant or prevent them from complying with this protocol.",true,"ALL","2 Years","17 Years",{"count":22,"type":23},1765,"ESTIMATED","INTERVENTIONAL",[26],"PHASE3","This randomized, double-blind, three parallel-group, multicenter, phase 3b trial evaluates the safety and immunogenicity of Butantan-DV. The study compares two primary immunization regimens (Butantan-DV\u002FButantan-DV vs. Butantan-DV\u002FPlacebo) across both the 2-11 and 12-17 age cohorts. It also evaluates the manufacturing facility transition for the Butantan-DV dengue vaccine, by comparing the open-label arm WuXi Biologics (Butantan-DV group) to both double-blinded Butantan-DV\u002FButantan-DV and Butantan-DV\u002FPlacebo arms, in adolescents aged 12 to 17.",[29],"Dengue Fever With Warning Signs",[31],"Dengue protection","NOT_YET_RECRUITING","2026-07-13",{"date":35,"type":36},"2026-07-20","ACTUAL",{"date":38,"type":23},"2027-02-01",{"date":40,"type":23},"2028-12-20",{"name":42,"class":43},"Butantan Institute","OTHER_GOV",{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":51,"targetDuration":53,"studyType":54,"phases":4,"briefSummary":55,"conditions":56,"keywords":60,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":75},"100624455","international-registry-of-dengue-infection-in-congenital-bleeding-disorders-denguecbdr-100624455","NCT07409857","International Registry of Dengue Infection in Congenital Bleeding Disorders (DengueCBDR)","DengueCBDR","Inclusion Criteria:\n\nPatients, aged ≥ 1 day old, diagnosed with CBDs (e.g., hemophilia, von Willebrand disease, and other coagulation factor deficiency) who are diagnosed with dengue infection, based on WHO criteria as follow;\n\nClinical dengue infection:\n\nSymptoms of high sustained fever for 3-7 days with 2 of the following: headache, retroorbital pain, myalgia, arthralgia\u002Fbone pain, hemorrhagic manifestation, positive tourniquet test, leukopenia (WBC ≤5000\u002FuL)\n\nProbable dengue infection:\n\nPositive dengue IgM\n\nDefinite dengue infection:\n\nSeroconversion of dengue IgM between acute and convalescent serum OR Rising of dengue IgG (HAI) at least 4 folds between acute and convalescent serum OR Positive NS1 Ag or other dengue-specific antigen tests\n\nDengue hemorrhagic fever:\n\nDengue infection with signs of bleeding (including positive tourniquet test) with platelet count \\\u003C 100,000\u002FuL and with signs of leakage (one of the following):\n\n1. Increase Hct at least 15-20% from baseline\n2. Serum albumin \\\u003C 35 g\u002FL\n3. Presence of pleural effusion or ascites\n\nDengue shock syndrome:\n\n1. Narrow pulse pressure (\\\u003C 20 mmHg)\n2. Hypotension\n3. Signs of poor tissue perfusion\n\nSeverity of DHF:\n\n* Grade I: Positive tourniquet test\n* Grade II: Spontaneous bleeding\n* Grade III: Circulatory failure (narrow pulse pressure ≤20 mmHg, hypotension, or signs of poor tissue perfusion)\n* Grade IV: Profound shock with undetectable blood pressure\n\nExclusion Criteria:\n\n* Patients with CBDs with dengue infection who are not willing to participate in the study",{"count":52,"type":23},100,"14 Days","OBSERVATIONAL","Dengue fever, a viral infection transmitted by Aedes mosquitoes, is a major health issue in tropical and subtropical regions. Around 20-30% of symptomatic patients developed Dengue Hemorrhagic Fever (DHF), which leads to impaired hemostasis, subsequently increasing the risk of bleeding.\n\nThe hemostatic abnormalities associated with dengue infection included vascular permeability, platelet dysfunction, and coagulation defects. Therefore, Individuals with underlying bleeding disorders are at increased risk of bleeding. Dengue infection in patients with hemophilia was reported, including six of 843 patients in the cohort with underlying hemophilia: five with hemophilia A and one with hemophilia B. Replacement therapy was more commonly used in patients with bleeding disorders and dengue than in patients with other febrile illnesses. All of them had bleeding during dengue infection. The mortality rate was high at 16%.\n\nDespite the importance of this issue, there is a lack of registries or data-collection systems to determine the bleeding complications, the requirement for replacement therapy, and the outcome of dengue infection in congenital bleeding disorders (CBDs). Therefore, this research aims to establish a registry of dengue infections among individuals with CBDs.\n\nThe study is a multicenter, retrospective study from 1 January 2015 to 31 December 2025 and a prospective cohort study involving hospitals that treat individuals with CBDs and dengue. The registry format will be provided using REDCap system.",[57,58,59,29],"Dengue Disease","Dengue Haemorrhagic Fever","Dengue Fever",[61,62,63],"Dengue","Congenital bleeding disorders","Replacement","RECRUITING","2026-02-12",{"date":67,"type":36},"2026-02-17",{"date":69,"type":36},"2025-12-01",{"date":71,"type":23},"2030-12-31",{"name":73,"class":74},"Mahidol University","OTHER",1,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":18,"minAge":84,"maxAge":4,"enrollmentInfo":85,"targetDuration":86,"studyType":54,"phases":4,"briefSummary":87,"conditions":88,"keywords":89,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":75},"100593526","risk-factors-for-hospitalization-and-transfusion-criteria-in-patients-with-dengue-virus-infection-100593526","NCT07007585","Risk Factors for Hospitalization and Transfusion Criteria in Patients With Dengue Virus Infection","Risk Factors for Hospitalization and Transfusion Criteria in Patients With Dengue Virus Infection: A Prospective Observational Study","DENGUE-FACT","Inclusion Criteria:\n\n* Patients aged ≥5 years\n* Laboratory-confirmed dengue infection (NS1, IgM, or PCR)\n* First contact at emergency or outpatient services\n* Informed consent signed by the patient or legal guardian\n\nExclusion Criteria:\n\n* Co-infection with other arboviruses or COVID-19\n* Pre-existing hematologic or oncologic disease\n* Refusal to sign informed consent","5 Years",{"count":52,"type":23},"1 Month","This 3-year prospective observational study aims to identify clinical and laboratory risk factors associated with hospitalization in patients with confirmed dengue virus infection. It also seeks to analyze real-world transfusion practices and their outcomes. The study will be conducted in a second-level hospital in northern Mexico and will follow patients from emergency department entry to clinical resolution or hospital discharge.",[61,59,29],[61,90,91,92,93,94],"Hospitalization","Transfusion","Hemorrhagic Fever","Thrombocytopenia","Mexico","2025-09-13",{"date":97,"type":36},"2025-09-16",{"date":99,"type":36},"2025-08-01",{"date":101,"type":23},"2028-08-30",{"name":103,"class":74},"Jose Ivan Rodriguez de Molina Serrano"]