[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"severe-anemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:severe-anemia":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100633204","phase-4-anemia-therapy-in-patients-with-infective-endocarditis-100633204",false,"NCT07523646","Anemia Therapy in Patients With Infective Endocarditis","Anemia Therapy in Patients With Infective Endocarditis (POET-IRON)","POET-IRON","Inclusion Criteria:\n\n* 18 years or older\n* Confirmed bacterial endocarditis.\n* Hb ≤6.0 mmol\u002Fl\n* Stabilization criteria:\n\n  * Stable condition (patients with satisfactory clinical response to initial treatment)\n  * At least 10 days with IV administered antibiotic treatment and at least 7 days after surgery in cases of valve surgery.\n  * Transesophageal echocardiography (TEE) performed prior to randomization with no signs of abscess formation or valve abnormalities, which would require surgery.\n  * No fever for at least 48 hours prior to enrollment.No positive blood cultures within last 4 days prior to randomization.\n  * CRP \\\u003C 25 mg\u002FL OR \\> 25% reduction from peak value.\n  * Leucocytes \\\u003C15 mia.\u002FL OR \\> 25% reduction from peak value.\n\nExclusion Criteria:\n\n* Known or suspected immunocompromise (e.g., HIV infection, ongoing chemotherapy, systemic corti-costeroid treatment \\>20 mg prednisolone equivalent\u002Fday)\n* Inability to provide informed consent for participation\n* Relapsing infective endocarditis (endocarditis caused by the same microorganism within 6 months)\n* Allergy \u002F intolerance to EPO or iron therapy\n* Inability to complete a 6MWT\n* Hematological conditions, that contradicts use of IV iron therapy\n* Death prior to clinical stabilization\n* Failure to fulfill criteria of clinical stabilization","ALL","18 Years",{"count":20,"type":21},74,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","Infective endocarditis (IE) is a bacterial infection of the heart valves, inserted material or surrounding struc-tures and is associated with a high morbidity and mortality. In patients with IE, anemia is considered to result from the underlying infection, prolonged sustained inflammatory response due to the often slow natural course of the disease, and coexisting comorbidities.\n\nPrevious studies have found that moderate to severe anemia is associated with a markedly higher risk of mortality in the 6-months recovery phase following treatment for IE. In many cardiac patients and patients with chronic inflammation, randomized trials have shown benefit of treatment of anemia with adjunctive therapy i.e., vitamins (vitamin B12\u002Ffolic acid), intravenous iron, and erythropoiesis stimulating agents in alleviating anemia, without increased risk of infection. Despite these findings, anemia screening and management are not addressed in current endocarditis guidelines. Thus, in patients with IE and anemia, adjunctive treatment of the anemia might be beneficial for recovery and improve outcomes.\n\nThe aim of POET-IRON is to assess the efficacy of adjunctive anemia treatment in patients with IE, using intravenous iron supplementation, erythropoietin-stimulated erythropoiesis, and dietary optimization including vitamins if necessary, and its effect on hemoglobin levels compared to standard care.\n\nThe investigators hypothesize that this intervention is safe and will increase hemoglobin concentration, thereby alleviating symptoms of anemia and improving clinical outcomes through enhanced oxygen-carrying capacity, tissue oxygenation, and functional status.",[27,28],"Infective Endocarditis (IE)","Severe Anemia",[30,31,32],"Anemia","Infective Endocarditis","Inflammation","RECRUITING","2026-05-26",{"date":36,"type":37},"2026-05-29","ACTUAL",{"date":39,"type":37},"2026-05-15",{"date":41,"type":21},"2028-08",{"name":43,"class":44},"Rigshospitalet, Denmark","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":45},"100564089","phase-4-pdmc-implementation-trial-in-kenya-100564089","NCT06624631","PDMC Implementation Trial in Kenya","Delivery Strategies for Malaria Chemoprevention in the Post-discharge Management of Children Hospitalised With Severe Anaemia or Severe Malaria: Cluster and Individually Randomised Controlled Implementation Trial and Economic Evaluation in Kenya","PDMC-SL","Inclusion Criteria:\n\nCLUSTERS\n\n* Health facilities with blood transfusion services offering in-patient care for children with severe anaemia and severe malaria.\n* \\>=40 children per year admitted with severe anaemia or severe malaria\n* Agreement to participate by facility management\n* Located in areas with moderate to high malaria transmission\n\nINDIVIDUAL PARTICIPANTS\n\n* Aged \\\u003C10 years of both sexes\n* Hospitalised with severe anaemia or severe malaria: Initially hospitalised with haemoglobin \\\u003C5.0 g\u002Fdl or PCV \\\u003C15%, or requirement for blood transfusion for other clinical reasons on or during admission to the hospital, or severe malaria, defined as a requirement for parenteral artesunate in the opinion of the treating clinician and\u002For the presence of microscopy or RDT confirmed Plasmodium infection\n\nExclusion Criteria:\n\nCLUSTERS\n\n\\- Health facilities without subservient lower-level health facilities\n\nINDIVIDUAL PARTICIPANTS\n\n* Recognised specific other causes of severe anaemia (i.e., trauma, haematological malignancy, known bleeding disorders, such as haemophilia)\n* Sickle cell anaemia\u002Fsickle cell disease\n* Body weight \\\u003C5 kg\n* HIV infection and cotrimoxazole prophylaxis are not exclusion criteria.","9 Years",{"count":56,"type":21},600,[24],"The goal of this implementation trial is to evaluate at least two alternative delivery strategies and adherence support for malaria chemoprevention with dihydroartemisinin-piperaquine in the post-discharge management of children hospitalised with severe anaemia or severe malaria to optimise adherence in Kenya.\n\nThe actual interventions to be evaluated have been co-designed with national stakeholders during an initial formative research stage.",[60,28],"Severe Malaria",[62,63,64,65,66,67,68,69,70,71,72,73,74,75,76],"Children","Antimalarial","Prevention","Chemoprevention","Caregivers","Patient discharge","Healthcare providers","Health economics","Qualitative research","Feasibility","Cost effectiveness","Kenya","Artemisinins","School age","Pre-school","2025-11-18",{"date":79,"type":37},"2025-11-21",{"date":81,"type":37},"2025-09-05",{"date":83,"type":21},"2026-09-30",{"name":85,"class":44},"Liverpool School of Tropical Medicine"]