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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Start prophylactic oral antibiotics | Other | Once daily trimethoprim-sulfamethoxazole (co-trimoxazole) 160mg/800mg. NB: Doxycycline 100mg daily as an alternative for patients with hypersensitivity to co-trimoxazole. |
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| Arm B: Start immunoglobulin replacement | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trimethoprim / Sulfamethoxazole | Drug | Once daily trimethoprim-sulfamethoxazole (co-trimoxazole) 160mg/800mg. NB: Doxycycline 100mg daily as an alternative for patients with hypersensitivity to co-trimoxazole. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of at least one Grade 3 or higher infection(s) from randomisation to 12 months. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zoe McQuilten, Professor | Monash University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Adelaide Hospital | Recruiting | Adelaide | South Australia | 5000 | Australia |
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| Label | URL |
|---|---|
| Study Website | View source |
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Individual participant data will not be publicly available. Data will only be presented as a whole, no individual data will be published or presented.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 12, 2023 | Jun 10, 2025 |
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Up to 900 participants will be recruited to the RATIONAL-PT, including up to 300 per domain. The aim of the platform is to determine optimal supportive care interventions for patients with haematological malignancies. The primary outcome for the platform is 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. Data from each domain will contribute to the primary analysis.
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An independent outcome adjudication committee will meet to review and adjudicate infection outcome data. These committee members will be blinded to treatment allocation.
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| Immune Globulin Intravenous | Biological | 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. |
|
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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. | 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. | 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. | 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). |
| All-cause mortality at 12 months. | All-cause mortality at 12 months. | 12 months following randomisation (or, in domains with a single treatment arm, time from registration). |
| Infection-related mortality at 12 months. | Infection-related mortality at 12 months. | 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 free from hospitalisation with antimicrobial administration with therapeutic intent 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 treatment-related adverse events. | Occurrence of one or more treatment-related adverse events. | 12 months following randomisation (or, in domains with a single treatment arm, time from registration). |
| Number of treatment-related adverse events. | Number of treatment-related adverse events. | 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. | Isolation of fluoroquinolone resistant organisms, co-trimoxazole resistant organisms, extended spectrum beta lactamases or multidrug resistant organisms from randomisation to 12 months. | 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. | 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. | 12 months following randomisation (or, in domains with a single treatment arm, time from registration). |
| Quality of Life (QoL) measured at randomisation then 3, 6, 9 and 12 months, using different questionnaire. | Quality of Life (QoL) measured at randomisation then 3, 6, 9 and 12 months, using different questionnaire. | Randomisation, Month 3, Month 6, Month 9 and Month 12. |
| Costs associated with allocated treatment arm and infections during study. | 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. | 12 months following randomisation (or, in domains with a single treatment arm, time from registration). |
| Austin Hospital | Recruiting | Melbourne | Victoria | 3004 | Australia |
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| Northern Health | Recruiting | Melbourne | Victoria | 3004 | Australia |
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| Prot_000.pdf |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D007239 | Infections |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D015662 | Trimethoprim, Sulfamethoxazole Drug Combination |
| D005719 | gamma-Globulins |
| ID | Term |
|---|---|
| D013420 | Sulfamethoxazole |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013424 | Sulfanilamides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D014295 | Trimethoprim |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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