Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy Dosing Immunoglobulin (Dose Ig)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Immune Globulin Intravenous.
- Who it may be relevant to
- Registry conditions: Myeloma, Non Hodgkin's Lymphoma, Leukemia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy (Dose-Ig)
Overview
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.
Detailed description
This is a domain within the RATIONAL Platform Trial to test the effectiveness and safety of prophylactic antibiotics as an alternative Ig replacement in patients who have not yet commenced Ig replacement therapy.
Interventions
- Biological Immune Globulin Intravenous
Participants will be treated with intravenous immunoglobulin monthly (every 4 weeks ± 1 week).
Primary outcome measures
- Event-free survival (EFS). [Time frame: 12 months following randomisation (or, in domains with a single treatment arm, time from registration)]
Secondary outcome measures (12)
- Occurrence of at least one Grade 3 or higher infection(s) from randomisation to 12 months. [Time frame: 12 months following randomisation (or, in domains with a single treatment arm, time from registration).]
- Occurrence of one or more clinically documented infections (symptoms/signs of infection requiring antimicrobial treatment) from randomisation to 12 months. [Time frame: 12 months following randomisation (or, in domains with a single treatment arm, time from registration).]
- Number of clinically documented infections (symptoms/signs of infection requiring antimicrobial treatment) from randomisation to 12 months. [Time frame: 12 months following randomisation (or, in domains with a single treatment arm, time from registration).]
- Occurrence of one or more microbiologically documented infections from randomisation to 12 months. [Time frame: 12 months following randomisation (or, in domains with a single treatment arm, time from registration).]
- Number of microbiologically documented infections from randomisation to 12 months. [Time frame: 12 months following randomisation (or, in domains with a single treatment arm, time from registration).]
- All-cause mortality at 12 months. [Time frame: 12 months following randomisation (or, in domains with a single treatment arm, time from registration).]
- Infection-related mortality at 12 months. [Time frame: 12 months following randomisation (or, in domains with a single treatment arm, time from registration).]
- Time free from hospitalisation with antimicrobial administration with therapeutic intent from randomisation to 12 months. [Time frame: 12 months following randomisation (or, in domains with a single treatment arm, time from registration).]
- Occurrence of one or more treatment-related adverse events. [Time frame: 12 months following randomisation (or, in domains with a single treatment arm, time from registration).]
- Number of treatment-related adverse events. [Time frame: 12 months following randomisation (or, in domains with a single treatment arm, time from registration).]
- Isolation of fluoroquinolone resistant organisms, co-trimoxazole resistant organisms, extended spectrum beta lactamases or multidrug resistant organisms from randomisation to 12 months. [Time frame: 12 months following randomisation (or, in domains with a single treatment arm, time from registration).]
- Number of infections with fluoroquinolone resistant organisms, co-trimoxazole resistant organisms, extended spectrum beta lactamases or multidrug resistant organisms isolated from randomisation to 12 months. [Time frame: 12 months following randomisation (or, in domains with a single treatment arm, time from registration).]
Eligibility criteria
Inclusion criteria
- Patients must be receiving IVIg replacement at standard dose for prevention of bacterial infections due to hypogammaglobulinaemia for at least 6 consecutive months.
- Patient is not eligible for trial of Ig cessation in the opinion of the treating clinician and local investigator.
Exclusion criteria
- Prior or planned allogeneic haematopoietic stem cell transplantation.
- Major infection (Grade 3 or higher) in preceding 3 months, and or current active infection requiring systemic antimicrobial treatment.
- Previous splenectomy.
- Known history of bronchiectasis.
- Previous participation in this domain.
- Treating team deems enrolment in the domain is not in the best interest of the patient.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Australia · 3 centers
- Royal Adelaide Hospital — Adelaide
- Austin Hospital — Melbourne
- Northern Health — Melbourne
Identifiers
NCT: NCT07202065 · TRU-RPT-22 Dose-Ig