None listed
Conditions
Brief summary
The aim of this study is to examine whether oral antibiotics can be used instead of intravenous immunoglobulin (IVIg) to reduce the risk of infections in people with blood cancers. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have an acquired hypogammaglobulinaemia secondary to a haematological malignancy. Study details Participants will be randomised (allocated by chance) to one of two treatment groups in a 2:1 ratio meaning that you are twice as likely to receive intervention treatment. Participants in one group (intervention) will receive co-trimoxazole (Trimethoprim-sulfamethoxazole) 160mg/800mg orally once a day or doxycycline 100mg once daily for those hypersensitive to co-trimoxazole. Participants in the second group (control) will receive standard care treatment with intravenous or subcutaneous immunoglobulin (IVIg or SCIg) in accordance with national Criteria: Monthly (every 4 weeks +/- 1 week) dose of 0.4g/kg, modified to achieve an IgG trough level of at least lower limit of age specific serum IgG reference range. The duration of each treatment is for 12 months from study entry, or until the treating physician determines that the patient should come off the treatment. The following data will be collected: Patient demographics (age, gender, diagnosis, stage of disease), baseline investigations (including IgG levels), grade 3 or 4 infections and other clinically significant infections – at monthly intervals for 12 months. This project aims to improve how we use IVIg in Australia by asking: Are prophylactic (preventive) oral antibiotics equivalent to immunoglobulin
Interventions
Prophylactic oral antibiotics: For up to 12 months.
Trimethoprim-sulfamethoxazole (co-trimoxazole) 160mg/800mg once daily tablet.
For patients with hypersensitivity to co-trimoxazole, doxycycline 100mg once daily tablet.
If a participant on the antibiotic arm has a Grade 3 or higher infectious complication, he/she will be discontinued on the treatment arm and be allowed to cross-over into the Ig (IVIg/SCIg) arm. Patients will not come off study. Data about such an event will be collected using
Prophylactic oral antibiotics: For up to 12 months. Trimethoprim-sulfamethoxazole (co-trimoxazole) 160mg/800mg once daily tablet. For patients with hypersensitivity to co-trimoxazole, doxycycline 100mg once daily tablet. If a participant on the antibiotic arm has a Grade 3 or higher infectious complication, he/she will be discontinued on the treatment arm and be allowed to cross-over into the Ig (IVIg/SCIg) arm. Patients will not come off study. Data about such an event will be collected using a specific case report form. The decision to discontinue treatment will be made by the treating clinician
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients are eligible for this trial if: 1 Age greater than or equal to 18 years 2 Acquired hypogammaglobulinaemia secondary to a haematological malignancy 3 Meet the Australian National Blood Authority Criteria for the Clinical Use of intravenous immunoglobulin (IVIg) for secondary hypogammaglobulinaemia (i.e. total IgG below local lower limit of reference range [excluding paraprotein] and history of recurrent or severe bacterial infection(s) OR IgG < 4 g/L [excluding paraprotein]) 4 Life expectancy > 12 months. 5 Willing and able to attend for monthly IVIg infusion or to self-administer subcutaneous immunoglobulin. 6 Able to give informed consent to participate.
Exclusion criteria
Patients will not be eligible for this study if they fulfil any of the following criteria: 1 Patient unwilling or unable to give informed consent. 2 llogeneic haematopoietic stem cell transplantation recipient. 3 Patient has an objection to receiving immunoglobulin. 4 Known severe IgA deficiency 5 History of anaphylactic reaction to human immunoglobulin preparation 6 Patient already receiving daily antibiotic prophylaxis for the purpose of preventing bacterial infection. Patients receiving dapsone or intermittently-dosed cotrimoxazole for PJP prophylaxis are not excluded from the study. 7 Patient has received immunoglobulin replacement in the preceding 3 months 8 Current active infection requiring systemic antimicrobial agents 9 Anticipated prolonged significant cytopenias, defined by neutrophils < 0.5 x10^9/L or platelets < 50 x10^9/L, precluding regular cotrimoxazole. Temporary cytopenia/s due to therapy are not an exclusion. 10 History of epilepsy 11 Pregnant or breastfeeding 12 Severe renal impairment (creatinine clearance of <30ml/min) 13 Previous splenectomy
Outcome results
None listed