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NCT Number: NCT07202065

Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy Dosing Immunoglobulin (Dose Ig)

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.

Recruiting

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Key information

Conditions

Myeloma Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Infections Leukemia Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Non Hodgkin's Lymphoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Royal Adelaide Hospital, Adelaide, South Australia, Australia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Immune Globulin Intravenous

Biological

Participants will be treated with intravenous immunoglobulin monthly (every 4 weeks ± 1 week).

Other names: IVIG

Primary outcomes

  1. Event-free survival (EFS).

    Time frame: 12 months following randomisation (or, in domains with a single treatment arm, time from registration)

    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.

Secondary outcomes

  1. 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 at least one Grade 3 or higher infection(s) from randomisation to 12 months.

  2. 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).

    Occurrence of one or more clinically documented infections (symptoms/signs of infection requiring antimicrobial treatment) from randomisation to 12 months.

  3. 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).

    Number of clinically documented infections (symptoms/signs of infection requiring antimicrobial treatment) from randomisation to 12 months.

  4. 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).

    Occurrence of one or more microbiologically documented infections from randomisation to 12 months.

  5. 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).

    Number of microbiologically documented infections from randomisation to 12 months.

  6. All-cause mortality at 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.

  7. Infection-related 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.

  8. 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).

    Time free from hospitalisation with antimicrobial administration with therapeutic intent from randomisation to 12 months.

  9. 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).

    Occurrence of one or more treatment-related adverse events.

  10. Number of 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.

  11. 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).

    Isolation of fluoroquinolone resistant organisms, co-trimoxazole resistant organisms, extended spectrum beta lactamases or multidrug resistant organisms from randomisation to 12 months.

  12. 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).

    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.

  13. Quality of Life (QoL) measured at randomisation then 3, 6, 9 and 12 months, using different questionnaire.

    Time frame: Randomisation, Month 3, Month 6, Month 9 and Month 12

    Quality of Life (QoL) measured at randomisation then 3, 6, 9 and 12 months, using different questionnaire.

  14. Costs associated with allocated treatment arm and infections during study.

    Time frame: 12 months following randomisation (or, in domains with a single treatment arm, time from registration).

    Costs of infections and trial interventions will be estimated based on trial treatment and adverse event data within the hospital medical record, as well as linked data obtained from the Medicare Benefits Scheme (MBS), Pharmaceutical Benefits Scheme (PBS) and Australian Immunisation Register (AIR). Data from the quality of life questionnaires will be used to calculate quality adjusted life years.

Sponsors and collaborators

Lead sponsor

Monash University

Other

Registry information

Official study title

Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy (Dose-Ig)

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 1, 2025
Registry last updated
Oct 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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