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Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy Platform Trial (RATIONAL-PT)

RecruitingPhase 2, Phase 3Ages 18 Years - anyAllMonash University
NCT07202052 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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. It is a comparison between Immunoglobulin and antibiotics use.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Aged greater than or equal to 18 years of age 2. Diagnosis of haematological malignancy, including (CLL) chronic lymphocytic leukemia, (MM) multiple myeloma or (NHL) non-Hodgkin's lymphoma. 3. 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\<4g/L (excluding paraprotein) 4. Life expectancy \> 12 months 5. Able to give informed consent Exclusion Criteria: 1\. Treating team deems enrolment in the study is not in the best interests of the patient.
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What it tests

  • Intravenous immunoglobulin
  • Trimethoprim / Sulfamethoxazole
  • Amoxicillin clavulanic acid
  • Intravenous immunoglobulin (IVIG)
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Where

3 sites
Royal Adelaide Hospital
Adelaide, Australia
Austin Hospital
Melbourne, Australia
Northern Health
Melbourne, Australia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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