Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy: Starting Immunoglobulin (Start Ig)
Recruiting now · Phase 2/Phase 3
Conditions studied: Myeloma, Non Hodgkin's Lymphoma, Leukemia
In brief
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. This 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. The 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.
Key facts
- Study ID
- NCT07202078
- Run by
- Monash University
- People needed
- 900
- Starts
- 2025-05-07
- Expected to finish
- 2027-03-31
- Last updated by the study team
- 2025-10-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- None.
You may not qualify if…
- 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.
Where it is running
- Royal Adelaide Hospital — Adelaide, South Australia, Australia (enrolling)
- Austin Hospital — Melbourne, Victoria, Australia (enrolling)
- Northern Health — Melbourne, Victoria, Australia (enrolling)
Full record on ClinicalTrials.gov
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