[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608476":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":50,"centralContacts":49,"locations":54,"responsibleParty":110,"collaborators":49,"id":112,"slug":113,"hasResults":114,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":49,"eligibilityCriteria":118,"healthyVolunteers":114,"sex":119,"minAge":120,"maxAge":49,"enrollmentInfo":121,"targetDuration":49,"studyType":124,"phases":125,"briefSummary":128,"conditions":129,"keywords":133,"overallStatus":57,"whyStopped":49,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":154},{"fullName":5,"class":6},"Monash University","OTHER",[8,14,19],{"label":9,"type":6,"description":10,"interventionNames":11},"Start Immunoglobulin","Patients eligible to start immunoglobulin are randomly assigned to:\n\n* receive either prophylactic antibiotic\n* or Ig replacement.",[12,13],"Biological: Intravenous immunoglobulin","Drug: Trimethoprim \u002F Sulfamethoxazole",{"label":15,"type":6,"description":16,"interventionNames":17},"Stop Immunoglobulin","Patients eligible to stop immunoglobulin are randomly assigned to:\n\n* Stop Ig and take daily antibiotics\n* Stop Ig and take antibiotics only when infections occur\n* Continue Ig therapy",[12,13,18],"Drug: Amoxicillin clavulanic acid",{"label":20,"type":6,"description":21,"interventionNames":22},"Dose Immunoglobulin","Patients receiving IVIg are randomly assigned to:\n\n* Continue with standard dose (0.4 g\u002Fkg)\n* Switch to a lower dose (0.25 g\u002Fkg)",[23],"Biological: Intravenous immunoglobulin (IVIG)",[25,32,39,45],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"BIOLOGICAL","Intravenous immunoglobulin","(IVIg) intravenous immunoglobulin every 4 weeks ± 1 week at a dose of 0.4g\u002Fkg, modified to achieve an (IgG) immunoglobulin G trough level of at least lower limit of age-specific serum IgG reference range; or SCIg, weekly, may be used in patients who meet local criteria for home-based self-administration in centres with established SCIg programs. Dosing is usually given at 100mg\u002Fkg\u002Fweek, modified to achieve an IgG steady state level of at least the lower limit of the serum reference range. A loading IVIg dose may be given in the first month if required.",[9,15],[31],"Subcutaneous immunoglobulin",{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"DRUG","Trimethoprim \u002F Sulfamethoxazole","Once daily trimethoprim-sulfamethoxazole (co-trimoxazole) 160mg\u002F800mg. Doxycycline 100mg daily as an alternative for patients with hypersensitivity to co-trimoxazole.",[9,15],[38],"co-trimoxazole",{"type":33,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"Amoxicillin clavulanic acid","Patients will be provided with amoxycillin\u002Fclavulanic acid 1750-2000mg\u002F250mg and ciprofloxacin 750 mg to keep at home for initial use if symptoms of infection develop, with immediate review by their treating clinical team, or nearest emergency department or medical practitioner with phone contact to treating team if most practical. Clindamycin 600 mg is permitted as an alternative to amoxycillin\u002Fclavulanic acid for patients with hypersensitivity to penicillin. Ciprofloxacin is omitted for participants with hypersensitivity.",[15],[44],"Ciprofloxacin",{"type":26,"name":46,"description":47,"armGroupLabels":48,"otherNames":49},"Intravenous immunoglobulin (IVIG)","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 levels is required.\n\nArm 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 reference range.",[20],null,[51],{"name":52,"affiliation":5,"role":53},"Zoe McQuilten, Professor","PRINCIPAL_INVESTIGATOR",[55,79,97],{"facility":56,"status":57,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Royal Adelaide Hospital","RECRUITING","Adelaide","South Australia","5000","Australia","AU",{"type":64,"coordinates":65},"Point",[66,67],138.59863,-34.92866,{"lat":67,"lon":66},[70,75],{"name":71,"role":72,"phone":73,"phoneExt":49,"email":74},"Peter Bardy","CONTACT","+61 (8) 7074 5898","peter.bardy@sa.gov.au",{"name":76,"role":72,"phone":77,"phoneExt":49,"email":78},"Chris Hoare","+61 08 7074 3290","christine.hoare@sa.gov.au",{"facility":80,"status":57,"city":81,"state":82,"zip":83,"country":61,"countryCode":62,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"Austin Hospital","Melbourne","Victoria","3004",{"type":64,"coordinates":85},[86,87],144.96332,-37.814,{"lat":87,"lon":86},[90,94],{"name":91,"role":72,"phone":92,"phoneExt":49,"email":93},"Andrew Lim, Dr","+61 (03) 9070 5741","andrew.lim@austin.org.au",{"name":95,"role":72,"phone":49,"phoneExt":49,"email":96},"Selena Squillaciotti","Selena.SQUILLACIOTI@austin.org.au",{"facility":98,"status":57,"city":81,"state":82,"zip":83,"country":61,"countryCode":62,"cosmosGeoPoint":99,"geoPoint":101,"contacts":102},"Northern Health",{"type":64,"coordinates":100},[86,87],{"lat":87,"lon":86},[103,107],{"name":104,"role":72,"phone":105,"phoneExt":49,"email":106},"Rachel Cooke, PhD","+61 (03) 8408 6000","rachel.cooke@nh.org.au",{"name":108,"role":72,"phone":49,"phoneExt":49,"email":109},"Rhiannon Davidson","rhiannon.davidson@nh.org.au",{"type":111,"investigatorFullName":49,"investigatorTitle":49,"investigatorAffiliation":49,"oldNameTitle":49,"oldOrganization":49},"SPONSOR","100608476","phase-2-role-of-antibiotic-therapy-or-immunoglobulin-on-infections-in-haematology-platform-trial-rational-pt-100608476",false,"NCT07202052","Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy Platform Trial (RATIONAL-PT)","A Randomised Platform Trial Evaluating the Role of Interventions to Prevent Infection in Patients With Acquired Hypogammaglobulinemia Secondary to Haematological Malignancies - RATIONAL-PT (Core)","Inclusion Criteria:\n\n1. Aged greater than or equal to 18 years of age\n2. Diagnosis of haematological malignancy, including (CLL) chronic lymphocytic leukemia, (MM) multiple myeloma or (NHL) non-Hodgkin's lymphoma.\n3. Eligible to receive or currently receiving Ig (IV or subcutaneous - SCIg) replacement for history of recurrent or severe infection(s) and IgG less than the lower limit of the reference range (excluding paraprotein) OR IgG\\\u003C4g\u002FL (excluding paraprotein)\n4. Life expectancy \\> 12 months\n5. Able to give informed consent\n\nExclusion Criteria:\n\n1\\. Treating team deems enrolment in the study is not in the best interests of the patient.","ALL","18 Years",{"count":122,"type":123},900,"ESTIMATED","INTERVENTIONAL",[126,127],"PHASE2","PHASE3","This is an adaptive platform study to find out how safe and effective different strategies are in comparison to each other, for preventing infection in patients with blood cancers.\n\nIt is a comparison between Immunoglobulin and antibiotics use.",[130,131,132],"Myeloma","Non-Hodgkin's Lymphoma","Leukemia",[134,135,136,137,138,139,140,141,142,143,144],"immunoglobulin","antibiotics","myeloma","leukaemia","lymphoma","non Hodgkins","infection","infections","blood","cancer","haematology","2025-10-01",{"date":147,"type":148},"2025-10-07","ACTUAL",{"date":150,"type":148},"2025-05-06",{"date":152,"type":123},"2027-03-31",{"name":5,"class":6},3]