Actively Recruiting

Phase 2
Phase 3
Age: 18Years +
All Genders
NCT05678621

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

Led by Monash University · Updated on 2024-04-19

300

Participants Needed

7

Research Sites

226 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 years or older
  • Diagnosed with chronic lymphocytic leukaemia, multiple myeloma, or non-Hodgkin lymphoma
  • Receiving intravenous or subcutaneous immunoglobulin to prevent bacterial infections for longer than 6 consecutive months
  • Eligible for immunoglobulin cessation based on treating clinician and local investigator opinion
  • Life expectancy longer than 12 months
  • Able to provide informed consent and comply with all treatment arms
Not Eligible

You will not qualify if you...

  • Prior or planned allogeneic haematopoietic stem cell transplantation
  • Major infection (Grade 3 or higher) within the past 3 months or current active infection requiring antimicrobial treatment
  • Already receiving daily antibiotic prophylaxis to prevent bacterial infections
  • Intolerance to all trial antibiotics in either antibiotic treatment arm
  • Communication, compliance, or logistical issues limiting ability to take antibiotics or seek urgent medical care
  • Pregnant or breastfeeding
  • Severe kidney impairment (creatinine clearance below 30 mL/min)
  • Previous splenectomy
  • Previous participation in this trial
  • Treating team considers study enrollment not in patient's best interest

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 7 locations

1

Canberra Hospital

Garran, Australian Capital Territory, Australia, 2605

Not Yet Recruiting

2

Concord Hospital

Concord, New South Wales, Australia, 2139

Actively Recruiting

3

Royal North Shore

St Leonards, New South Wales, Australia, 2065

Not Yet Recruiting

4

Monash Medical Centre

Clayton, Victoria, Australia, 3168

Actively Recruiting

5

Austin Hospital

Heidelberg, Victoria, Australia, 3084

Actively Recruiting

6

The Alfred Hospital

Melbourne, Victoria, Australia, 3004

Actively Recruiting

7

Sunshine Hospital

St Albans, Victoria, Australia, 3021

Actively Recruiting

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Research Team

P

Prof Zoe McQuilten

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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