Preventing infections in people with blood cancers using antibiotics or immunoglobulin

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This domain of the adaptive RATIONAL platform trial randomizes patients with blood cancers who are not on Ig replacement to receive either prophylactic antibiotics (trimethoprim–sulfamethoxazole) or intravenous immunoglobulin (IVIG). The trial uses an adaptive platform design to compare multiple prevention strategies concurrently, update analyses as data accrue, and add new questions over time. Primary outcomes focus on infection rates, safety, and healthcare utilization across participating Australian centers. The study spans phases 2 and 3 to capture both initial efficacy/safety signals and confirmatory outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* None.

Exclusion Criteria:

1. Prior or planned allogeneic haematopoietic stem cell transplantation.
2. Already receiving systemic antibiotic prophylaxis for the purpose of preventing bacterial infection (NB: patients may receive antiviral, antifungal and PJP prophylaxis).
3. Received immunoglobulin replacement in the preceding three months.
4. Objection to receiving immunoglobulin products.
5. Known history of IgA deficiency with anti-IgA.
6. History of severe allergy to immunoglobulin products.
7. Current active infection requiring systemic antibiotics.
8. Allergy or intolerance of all domain antibiotic options.
9. Pregnant or breastfeeding.
10. Severe renal impairment (estimated or measured creatinine clearance of \< 30 mL/min).
11. Previous splenectomy.
12. Previous participation in this domain.
13. Treating team deems enrolment in the domain is not in the best interest of the patient.

Where it's running

• Royal Adelaide Hospital
  Adelaide, South Australia, Australia Recruiting
• Austin Hospital
  Melbourne, Victoria, Australia Recruiting
• Northern Health
  Melbourne, Victoria, Australia Recruiting

Study contacts

• Principal investigator: Zoe McQuilten, Professor — Monash University

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.