Actively Recruiting

Phase 2
Phase 3
Age: 18Years +
All Genders
NCT07202078

Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy: Starting Immunoglobulin (Start Ig)

Led by Monash University · Updated on 2025-10-07

900

Participants Needed

3

Research Sites

99 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy: Starting Immunoglobulin (Start Ig)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

Age between 18 and 65 years Diagnosed with the specified medical condition Willing to follow all study procedures and visit schedules Able to provide informed consent and comply with study requirements

Not Eligible

You will not qualify if you...

  • Prior or planned allogeneic haematopoietic stem cell transplantation
  • Already receiving systemic antibiotic prophylaxis to prevent bacterial infection
  • Received immunoglobulin replacement in the last three months
  • Objection to receiving immunoglobulin products
  • Known IgA deficiency with anti-IgA antibodies
  • History of severe allergy to immunoglobulin products
  • Current active infection requiring systemic antibiotics
  • Allergy or intolerance to all antibiotic options in the domain
  • Pregnant or breastfeeding
  • Severe renal impairment with creatinine clearance below 30 mL/min
  • Previous splenectomy
  • Previous participation in this domain
  • Treating team considers enrolment not in patient's best interest

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Royal Adelaide Hospital

Adelaide, South Australia, Australia, 5000

Actively Recruiting

2

Austin Hospital

Melbourne, Victoria, Australia, 3004

Actively Recruiting

3

Northern Health

Melbourne, Victoria, Australia, 3004

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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