RecruitingPhase 2Phase 3NCT05678621

Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy: Immunoglobulin Stopping or Extension

A Randomised Controlled Trial of Continuing Immunoglobulin Therapy, or Stopping With or Without Prophylactic Antibiotics, on Infection Rate in Patients With Acquired Hypogammaglobulinemia Secondary to Haematological Malignancies.


Sponsor

Monash University

Enrollment

300 participants

Start Date

Nov 30, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether people with certain blood cancers (CLL, multiple myeloma, or non-Hodgkin lymphoma) who are currently receiving immune protein (immunoglobulin) infusions to prevent infections can safely switch to preventive antibiotics instead, or stop immunoglobulin therapy altogether. The goal is to find the least burdensome approach that still protects against infection. **You may be eligible if...** - You are 18 or older - You have been diagnosed with chronic lymphocytic leukemia (CLL), multiple myeloma, or non-Hodgkin lymphoma - You have been receiving immunoglobulin infusions to prevent infections for more than 6 months - Your doctor thinks you may be a candidate to try stopping or reducing immunoglobulin - Your life expectancy is greater than 12 months **You may NOT be eligible if...** - You have had a stem cell transplant or plan to have one - You have had a serious infection in the past 3 months - You are already on daily antibiotics for infection prevention - You are pregnant or breastfeeding - You have severe kidney problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGtrimethoprim-sulfamethoxazole (co-trimoxazole)

Doxycycline is an alternative for participants with hypersensitivity to co-trimoxazole.

DRUGamoxycillin/clavulanic acid and ciprofloxacin

clindamycin is an alternative to amoxycillin/clavulanic acid for participants with hypersensitivity to penicillin.

DRUGImmunoglobulins

Intravenous monthly immunoglobulin or subcutaneous weekly immunoglobulin


Locations(7)

Canberra Hospital

Garran, Australian Capital Territory, Australia

Concord Hospital

Concord, New South Wales, Australia

Royal North Shore

St Leonards, New South Wales, Australia

Monash Medical Centre

Clayton, Victoria, Australia

Austin Hospital

Heidelberg, Victoria, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Sunshine Hospital

St Albans, Victoria, Australia

View Full Details on ClinicalTrials.gov

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NCT05678621


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