Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy Platform Trial (RATIONAL-PT)
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorMonash University
About this trial
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.
Eligibility criteria
Qualifiers
Aged greater than or equal to 18 years of age
Diagnosis of haematological malignancy, including (CLL) chronic lymphocytic leukemia, (MM) multiple myeloma or (NHL) non-Hodgkin's lymphoma.
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)
Life expectancy > 12 months
Disqualifiers
None
Trial design
Treatments tested in this trial
- Intravenous immunoglobulin
- Trimethoprim / Sulfamethoxazole
- Amoxicillin clavulanic acid
- Intravenous immunoglobulin (IVIG)
Treatment groups
900 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov