[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608477":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":25,"centralContacts":29,"locations":30,"responsibleParty":86,"collaborators":29,"id":88,"slug":89,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":29,"eligibilityCriteria":94,"healthyVolunteers":90,"sex":95,"minAge":96,"maxAge":29,"enrollmentInfo":97,"targetDuration":29,"studyType":100,"phases":101,"briefSummary":104,"conditions":105,"keywords":109,"overallStatus":33,"whyStopped":29,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"fullName":5,"class":6},"Monash University","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"Arm A: Low dose (IgRT) immunoglobulin replacement therapy","Participants will be treated with intravenous immunoglobulin monthly (every 4 weeks ± 1 week) at a dose of 0.25g\u002Fkg. No dose adjustment for trough serum (IgG) immunoglobulin G levels is required.",[12],"Biological: Immune Globulin Intravenous",{"label":14,"type":6,"description":15,"interventionNames":16},"Arm B: Usual dose","Participants will be treated with intravenous immunoglobulin monthly (every 4 weeks ± 1 week) at a dose of 0.4g\u002Fkg, modified to achieve an IgG trough level of at least lower limit of age-specific serum (IgG) immunoglobulin G reference range.",[12],[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"BIOLOGICAL","Immune Globulin Intravenous","Participants will be treated with intravenous immunoglobulin monthly (every 4 weeks ± 1 week).",[9,14],[24],"IVIG",[26],{"name":27,"affiliation":5,"role":28},"Zoe McQuilten, Professor","PRINCIPAL_INVESTIGATOR",null,[31,55,73],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Royal Adelaide Hospital","RECRUITING","Adelaide","South Australia","5000","Australia","AU",{"type":40,"coordinates":41},"Point",[42,43],138.59863,-34.92866,{"lat":43,"lon":42},[46,51],{"name":47,"role":48,"phone":49,"phoneExt":29,"email":50},"Peter Bardy, Dr","CONTACT","+61 (8) 7074 5898","peter.bardy@sa.gov.au",{"name":52,"role":48,"phone":53,"phoneExt":29,"email":54},"Chris Hoare","+61 08 7074 3290","christine.hoare@sa.gov.au",{"facility":56,"status":33,"city":57,"state":58,"zip":59,"country":37,"countryCode":38,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"Austin Hospital","Melbourne","Victoria","3004",{"type":40,"coordinates":61},[62,63],144.96332,-37.814,{"lat":63,"lon":62},[66,70],{"name":67,"role":48,"phone":68,"phoneExt":29,"email":69},"Andrew Lim, Dr","+61 (03) 9070 5741","andrew.lim@austin.org.au",{"name":71,"role":48,"phone":29,"phoneExt":29,"email":72},"Selena Squillaciotti","Selena.SQUILLACIOTI@austin.org.au",{"facility":74,"status":33,"city":57,"state":58,"zip":59,"country":37,"countryCode":38,"cosmosGeoPoint":75,"geoPoint":77,"contacts":78},"Northern Health",{"type":40,"coordinates":76},[62,63],{"lat":63,"lon":62},[79,83],{"name":80,"role":48,"phone":81,"phoneExt":29,"email":82},"Rachel Cooke, PhD","+61 (03) 8408 6000","rachel.cooke@nh.org.au",{"name":84,"role":48,"phone":29,"phoneExt":29,"email":85},"Rhiannon Davidson","rhiannon.davidson@nh.org.au",{"type":87,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100608477","phase-2-role-of-antibiotic-therapy-or-immunoglobulin-on-infections-in-haematology-dosing-immunoglobulin-dose-ig-100608477",false,"NCT07202065","Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy Dosing Immunoglobulin (Dose Ig)","Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy (Dose-Ig)","Inclusion Criteria:\n\n1. Patients must be receiving IVIg replacement at standard dose for prevention of bacterial infections due to hypogammaglobulinaemia for at least 6 consecutive months.\n2. Patient is not eligible for trial of Ig cessation in the opinion of the treating clinician and local investigator.\n\nExclusion Criteria:\n\n1. Prior or planned allogeneic haematopoietic stem cell transplantation.\n2. Major infection (Grade 3 or higher) in preceding 3 months, and or current active infection requiring systemic antimicrobial treatment.\n3. Previous splenectomy.\n4. Known history of bronchiectasis.\n5. Previous participation in this domain.\n6. Treating team deems enrolment in the domain is not in the best interest of the patient.","ALL","18 Years",{"count":98,"type":99},900,"ESTIMATED","INTERVENTIONAL",[102,103],"PHASE2","PHASE3","This study is being conducted to find out how safe and effective different strategies of infection prevention are in comparison to each other, for preventing infection in patients with blood cancers. The best way to find out this information is to directly compare the effect of different treatment strategies in patients with blood cancers. We want to know how these different treatments impact on your health and your use of healthcare services.\n\nThis research project uses an Adaptive Platform Design. This design allows the researchers to compare multiple infection prevention strategies within the same trial at the same time (rather than running separate trials), to analyse results as the trial occurs and to add new research questions during the course of the trial.\n\nThe treatments that you may receive as part of the study will be determined by which domain(s) of the platform you participate in. By combining data collected within each domain as part of the platform, the researchers can investigate and compare treatment strategies and infection outcomes across a broader range of participants.",[106,107,108],"Myeloma","Non Hodgkin's Lymphoma","Leukemia",[110,111,112,113,114,115,116,117,118,119,120],"immunoglobulin","antibiotics","myeloma","leukaemia","lymphoma","non Hodgkins","infection","infections","blood","cancer","haematology","2025-10-01",{"date":123,"type":124},"2025-10-07","ACTUAL",{"date":126,"type":124},"2025-04-28",{"date":128,"type":99},"2027-03-31",{"name":5,"class":6},3]