Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy Platform Trial (RATIONAL-PT)
This is an adaptive platform study to find out how safe and effective different strategies are in comparison to each other, for preventing infection in patients with blood cancers. It is a comparison between Immunoglobulin and antibiotics use.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
- Aged greater than or equal to 18 years of age
- Diagnosis of haematological malignancy, including (CLL) chronic lymphocytic leukemia, (MM) multiple myeloma or (NHL) non-Hodgkin's lymphoma.
- Eligible to receive or currently receiving Ig (IV or subcutaneous - SCIg) replacement for history of recurrent or severe infection(s) and IgG less than the lower limit of the reference range (excluding paraprotein) OR IgG<4g/L (excluding paraprotein)
- Life expectancy > 12 months
- Able to give informed consent
Exclusion criteria
- Treating team deems enrolment in the study is not in the best interests of the patient.
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- PHASE2PHASE3
Study ID
NCT07202052
Intervention or treatment
BIOLOGICAL: Intravenous immunoglobulin
DRUG: Trimethoprim / Sulfamethoxazole
DRUG: Amoxicillin clavulanic acid
BIOLOGICAL: Intravenous immunoglobulin (IVIG)
Conditions
- Myeloma
- Non-Hodgkin's Lymphoma
- Leukemia
You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.
Research sites nearby
Closest Location:
Royal Adelaide Hospital
Select from list below to view details:
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Austin Hospital
Melbourne, Victoria, Australia
Northern Health
Melbourne, Victoria, Australia
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Who is running the clinical trial?
Monash University
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
OTHER: Start Immunoglobulin
| Biological: Intravenous immunoglobulin, Drug: Trimethoprim / Sulfamethoxazole |
OTHER: Stop Immunoglobulin
| Biological: Intravenous immunoglobulin, Drug: Trimethoprim / Sulfamethoxazole, Drug: Amoxicillin clavulanic acid |
OTHER: Dose Immunoglobulin
| Biological: Intravenous immunoglobulin (IVIG) |
What is the study measuring?
Primary Outcome
| 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) |
Secondary Outcome
| 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. | 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 | An adverse event includes any untoward medical occurrence that is not necessarily caused by the trial treatment. Examples of adverse events might include symptoms such as nausea, diarrhoea or headache. Adverse events will be collected via clinical examination, hospital medical record, or self-report to study team or via study diary. Adverse events will be graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5. Relationship to treatment will be assessed by an Investigator at the trial site. | 12 months following randomisation (or, in domains with a single treatment arm, time from registration) |
| Number of treatment-related adverse events. | An adverse event includes any untoward medical occurrence that is not necessarily caused by the trial treatment. Examples of adverse events might include symptoms such as nausea, diarrhoea or headache. Adverse events will be collected via clinical examination, hospital medical record, or self-report to study team or via study diary. Adverse events will be graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5. Relationship to treatment will be assessed by an Investigator at the trial site. | 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 the questionnaire. | Quality of Life (QoL) measured at randomisation then 3, 6, 9 and 12 months, using the 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) |
References
Clinical Trials Gov: Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy Platform Trial (RATIONAL-PT)Other trials to consider
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