Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy: Starting Immunoglobulin (Start Ig)
1 other identifier
interventional
900
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2025
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 7, 2025
CompletedFirst Submitted
Initial submission to the registry
September 24, 2025
CompletedFirst Posted
Study publicly available on registry
October 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2027
October 7, 2025
October 1, 2025
1.9 years
September 24, 2025
October 1, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Event-free survival (EFS).
Defined as time from randomisation (or, in domains with a single treatment arm, time from registration) until occurrence of a Grade 3 or higher infection (as defined by CTCAE Version 5), or death from any cause.
12 months following randomisation (or, in domains with a single treatment arm, time from registration).
Secondary Outcomes (14)
Occurrence of at least one Grade 3 or higher infection(s) from randomisation to 12 months.
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.
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.
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.
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.
12 months following randomisation (or, in domains with a single treatment arm, time from registration).
- +9 more secondary outcomes
Study Arms (2)
Arm A: Start prophylactic oral antibiotics
OTHEROnce daily trimethoprim-sulfamethoxazole (co-trimoxazole) 160mg/800mg. NB: Doxycycline 100mg daily as an alternative for patients with hypersensitivity to co-trimoxazole.
Arm B: Start immunoglobulin replacement
OTHERIVIg every 4 weeks ± 1 week at a dose of 0.4g/kg, modified to achieve an IgG trough level of at least lower limit of age-specific serum IgG reference range; or SCIg, weekly, may be used in patients who meet local criteria for home-based self-administration in centres with established SCIg programs. Dosing is usually given at 100mg/kg/week, modified to achieve an IgG steady state level of at least the lower limit of the serum reference range. A loading IVIg dose may be given in the first month if required.
Interventions
Once daily trimethoprim-sulfamethoxazole (co-trimoxazole) 160mg/800mg. NB: Doxycycline 100mg daily as an alternative for patients with hypersensitivity to co-trimoxazole.
IVIg every 4 weeks ± 1 week at a dose of 0.4g/kg, modified to achieve an IgG trough level of at least lower limit of age-specific serum IgG reference range; or SCIg, weekly, may be used in patients who meet local criteria for home-based self-administration in centres with established SCIg programs. Dosing is usually given at 100mg/kg/week, modified to achieve an IgG steady state level of at least the lower limit of the serum reference range. A loading IVIg dose may be given in the first month if required.
Eligibility Criteria
You may qualify if:
- None.
You may not qualify if:
- Prior or planned allogeneic haematopoietic stem cell transplantation.
- Already receiving systemic antibiotic prophylaxis for the purpose of preventing bacterial infection (NB: patients may receive antiviral, antifungal and PJP prophylaxis).
- Received immunoglobulin replacement in the preceding three months.
- Objection to receiving immunoglobulin products.
- Known history of IgA deficiency with anti-IgA.
- History of severe allergy to immunoglobulin products.
- Current active infection requiring systemic antibiotics.
- Allergy or intolerance of all domain antibiotic options.
- Pregnant or breastfeeding.
- Severe renal impairment (estimated or measured creatinine clearance of \< 30 mL/min).
- Previous splenectomy.
- Previous participation in this domain.
- Treating team deems enrolment in the domain is not in the best interest of the patient.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Austin Hospital
Melbourne, Victoria, 3004, Australia
Northern Health
Melbourne, Victoria, 3004, Australia
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zoe McQuilten, Professor
Monash University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- An independent outcome adjudication committee will meet to review and adjudicate infection outcome data. These committee members will be blinded to treatment allocation.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 24, 2025
First Posted
October 1, 2025
Study Start
May 7, 2025
Primary Completion (Estimated)
March 31, 2027
Study Completion (Estimated)
March 31, 2027
Last Updated
October 7, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share
Individual participant data will not be publicly available. Data will only be presented as a whole, no individual data will be published or presented.