Actively Recruiting
Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy Immunoglobulin Stopping or Extension (Stop Ig)
Led by Monash University · Updated on 2025-10-07
900
Participants Needed
3
Research Sites
99 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy Immunoglobulin Stopping or Extension (Stop Ig)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Receiving intravenous or subcutaneous immunoglobulin replacement for at least 6 consecutive months to prevent bacterial infections due to low immunoglobulin levels
- Considered eligible for Ig cessation trial by treating clinician and local investigator
- Willing and able to comply with all treatment arms of the study
You will not qualify if you...
- Prior or planned allogeneic hematopoietic stem cell transplantation
- Major infection (Grade 3 or higher) within the last 3 months or current active infection needing systemic antimicrobial treatment
- Currently receiving systemic antibiotic prophylaxis to prevent bacterial infection (antiviral, antifungal, or PJP prophylaxis allowed)
- Intolerance to all trial antibiotic options in either treatment arm
- Communication, compliance, or logistical issues likely to limit ability to take prophylactic or emergency antibiotics or seek urgent medical care
- Pregnant or breastfeeding
- Severe kidney impairment with creatinine clearance below 30 mL/min
- Previous removal of the spleen (splenectomy)
- Previous participation in this trial domain
- Treating team judges enrollment not in patient's best interest
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Actively Recruiting
2
Austin Hospital
Melbourne, Victoria, Australia, 3004
Actively Recruiting
3
Northern Health
Melbourne, Victoria, Australia, 3004
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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