The aim of the study is to find out if patients with blood cancers receiving immunoglobulin (Ig) for the purpose of preventing infections can safety stop immunoglobulin after six months of therapy, and take oral antibiotics instead to prevent serious infections. Patients may be eligible to join this study if they are aged 18 years or above, have an acquired hypogammaglobulinaemia secondary to a haematological malignancy, and have been receiving intravenous or subcutaneous Ig for longer than 6 consecutive months. Participants will be randomised (allocated by chance) to one of three treatment groups, as follows: * Stop immunoglobulin (IVIg or SCIg) and be given oral antibiotics to take every day (ARM A) * Stop immunoglobulin (IVIg or SCIg) and be given oral antibiotics to keep at home to use as soon as symptoms of an infection develop (ARM B) * Continue receiving immunoglobulin (IVIg or SCIg) - this is the usual care group (ARM C) The duration of each treatment is for 12 months from study entry. Participants will be asked to attend a screening/baseline visit so that their treating clinician can assess their eligibility for the trial and collect baseline data. If eligible for the trial, participants will then be randomly allocated to one of the three treatment groups. Once randomised, active participation in the study will last for 13 months. During this period, participants will be asked to return to the hospital for a study visit every 3 months, with monthly telephone visits to check-in on your progress between each in-person visit. Participants will also be asked to complete a study diary, recording treatment compliance and signs/symptoms of infection experienced throughout the study period. Types of assessments and data collected will include: Medical history, demographics, physical examination, blood tests, stool sample, quality of life questionnaires, information about your general health, hospitalisations, medications and procedures. In order to assess and compare the cost-effectiveness of the treatment groups, the study team will also request authorisation from participants to access their Medicare Benefits Schedule (MBS), Pharmaceutical Benefits Scheme (PBS), and Australian Immunisation Register (AIR) data.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
300
Doxycycline is an alternative for participants with hypersensitivity to co-trimoxazole.
clindamycin is an alternative to amoxycillin/clavulanic acid for participants with hypersensitivity to penicillin.
Intravenous monthly immunoglobulin or subcutaneous weekly immunoglobulin
Canberra Hospital
Garran, Australian Capital Territory, Australia
NOT_YET_RECRUITINGConcord Hospital
Concord, New South Wales, Australia
RECRUITINGRoyal North Shore
St Leonards, New South Wales, Australia
NOT_YET_RECRUITINGMonash Medical Centre
Clayton, Victoria, Australia
RECRUITINGAustin Hospital
Heidelberg, Victoria, Australia
RECRUITINGThe Alfred Hospital
Melbourne, Victoria, Australia
RECRUITINGSunshine Hospital
St Albans, Victoria, Australia
RECRUITINGEvent-free survival (EFS), defined as time from randomisation until occurrence of a Grade 3 or higher infection (as defined by CTCAE Version 5), or death from any cause.
Time frame: 12 months following randomisation
Proportion of patients who develop at least 1 Grade 3 or higher infection(s) from randomisation to 12 months.
Time frame: 12 months following randomisation
Proportion of patients with one or more clinically documented infections (symptoms/signs of infection requiring antimicrobial treatment) to 12 months.
Time frame: 12 months following randomisation
Number of clinically documented infections (symptoms/signs of infection requiring antimicrobial treatment) to 12 months. Data collected from medical records will inform this outcome measure.
Time frame: 12 months following randomisation
Proportion of patients with one or more microbiologically documented bacterial infections.
Time frame: 12 months following randomisation
Number of microbiologically documented bacterial infections.
Time frame: 12 months following randomisation
Time free from hospitalisation and antimicrobials with therapeutic intent.
Time frame: 12 months following randomisation
Proportion of patients with one or more treatment-related adverse events
Time frame: 12 months following randomisation
Number of treatment-related adverse events.
Time frame: 12 months following randomisation
Proportion of patients with fluoroquinolone resistant organisms, co-trimoxazole resistant organisms, extended spectrum beta lactamases or multidrug resistant organisms isolated.
Time frame: 12 months following randomisation
Number of infections with fluoroquinolone resistant organisms, co-trimoxazole resistant organisms, extended spectrum beta lactamases or multidrug resistant organisms isolated.
Time frame: 12 months following randomisation
Quality of Life (QoL) measured at randomisation then 3, 6, 9 and 12 months
QoL will be assessed using the EORTC QLQ-C30 questionnaire.
Time frame: Randomisation and 3, 6, 9 and 12 months following randomisation.
Quality of Life (QoL) measured at randomisation then 3, 6, 9 and 12 months
QoL will be assessed using the Functional Assessment of Cancer Therapy - Neutropenia (FACT-N) questionnaire.
Time frame: Randomisation and 3, 6, 9 and 12 months following randomisation.
Quality of Life (QoL) measured at randomisation then 3, 6, 9 and 12 months
QoL will be assessed using the EQ-5D-5L questionnaire.
Time frame: Randomisation and 3, 6, 9 and 12 months following randomisation.
Costs associated with allocated treatment arm and infections during study
Costs associated with each treatment arm with be aggregated into Australian dollars. Aggregate costs will be calculated based on the following data sources: medical records, infection-related hospitalisations (using unit costs based on unlinked data from the Victorian Admitted Episodes Dataset, Victorian Emergency Minimum Dataset and the Victorian Cost Data Collection), Medicare Benefits Scheme (MBS), Pharmaceutical Benefits Scheme (PBS) and Australian Immunisation Registry (AIR) data.
Time frame: 12 months following randomisation
Cost effectiveness of the allocated treatment arm
Differences in costs and Quality Adjusted Life Years (QALYs) for each of the treatment arms will be aggregated into a cost effectiveness ratio. The following data sources will be used to calculate this outcome measure: the EORTC QLQ-C30 questionnaire will be used to calculate QALYS. Costs will be calculated based on the following data sources: medical records, infection-related hospitalisations (using unit costs based on unlinked data from the Victorian Admitted Episodes Dataset, Victorian Emergency Minimum Dataset and the Victorian Cost Data Collection), Medicare Benefits Scheme (MBS), Pharmaceutical Benefits Scheme (PBS) and Australian Immunisation Registry (AIR) data.
Time frame: 12 months following randomisation
Trough IgG level at 3, 6, 9 and 12 months from baseline.
Time frame: 3, 6, 9 and 12 months from baseline
Proportion of patients in immunoglobulin cessation treatment arms who restart Ig over 12 months.
Time frame: 12 months following randomisation
Covid anti-spike protein levels at baseline, 3, 6, 9, and 12 months.
Time frame: 3, 6, 9 and 12 months following baseline
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