Status:
RECRUITING
Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy: Starting Immunoglobulin (Start Ig)
Lead Sponsor:
Monash University
Conditions:
Myeloma
Non Hodgkin's Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
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. ...
Detailed Description
This is a domain within the RATIONAL Platform Trial to test the effectiveness and safety of prophylactic antibiotics as an alternative Ig replacement in patients who have not yet commenced Ig replacem...
Eligibility Criteria
Inclusion
- None.
Exclusion
- Prior or planned allogeneic haematopoietic stem cell transplantation.
- Already receiving systemic antibiotic prophylaxis for the purpose of preventing bacterial infection (NB: patients may receive antiviral, antifungal and PJP prophylaxis).
- Received immunoglobulin replacement in the preceding three months.
- Objection to receiving immunoglobulin products.
- Known history of IgA deficiency with anti-IgA.
- History of severe allergy to immunoglobulin products.
- Current active infection requiring systemic antibiotics.
- Allergy or intolerance of all domain antibiotic options.
- Pregnant or breastfeeding.
- Severe renal impairment (estimated or measured creatinine clearance of \< 30 mL/min).
- Previous splenectomy.
- Previous participation in this domain.
- Treating team deems enrolment in the domain is not in the best interest of the patient.
Key Trial Info
Start Date :
May 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2027
Estimated Enrollment :
900 Patients enrolled
Trial Details
Trial ID
NCT07202078
Start Date
May 7 2025
End Date
March 31 2027
Last Update
October 7 2025
Active Locations (3)
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1
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
2
Austin Hospital
Melbourne, Victoria, Australia, 3004
3
Northern Health
Melbourne, Victoria, Australia, 3004