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A randomised controlled feasibility trial comparing the efficacy of prophylactic intravenous immunoglobulin with prophylactic antibiotics in patients with acquired hypogammaglobulinemia secondary to haematological malignancies
Other Non-Commercial Sponsor
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.
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.