Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy Immunoglobulin Stopping or Extension (Stop Ig)
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorMonash University
About this trial
This study is being conducted to find out how safe and effective different strategies of infection prevention are in comparison to each other, for preventing infection in patients with blood cancers. The best way to find out this information is to directly compare the effect of different treatment strategies in patients with blood cancers. We want to know how these different treatments impact on your health and your use of healthcare services.
This research project uses an Adaptive Platform Design. This design allows the researchers to compare multiple infection prevention strategies within the same trial at the same time (rather than running separate trials), to analyse results as the trial occurs and to add new research questions during the course of the trial.
The treatments that you may receive as part of the study will be determined by which domain(s) of the platform you participate in. By combining data collected within each domain as part of the platform, the researchers can investigate and compare treatment strategies and infection outcomes across a broader range of participants.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients must be receiving Ig (IV or subcutaneous - SCIg) replacement for prevention of bacterial infections due to hypogammaglobulinaemia for at least 6 consecutive months.
Patient is eligible for trial of Ig cessation in the opinion of the treating clinician and local investigator.
Patient is willing and able to comply with each of the treatment arms.
Disqualifiers
Prior or planned allogeneic haematopoietic stem cell transplantation.
Major infection (Grade 3 or higher) in preceding 3 months, and/or current active infection requiring systemic antimicrobial treatment.
Already receiving systemic antibiotic prophylaxis for the purpose of preventing bacterial infection (NB: patients may receive antiviral, antifungal and PJP prophylaxis).
Intolerance of all trial antibiotic options in either arm A or arm B.
Trial design
Design model
Parallel
Treatments tested in this trial
Trimethoprim Sulfamethoxazole
DrugOnce daily trimethoprim-sulfamethoxazole (co-trimoxazole) 160mg/800mg. NB: Doxycycline 100mg daily as an alternative for patients with hypersensitivity to co-trimoxazole.
Amoxycillin/clavulanic acid
DrugPatients will be provided with amoxycillin/clavulanic acid 1750-2000mg/250mg and ciprofloxacin 750 mg to keep at home for initial use if symptoms of infection develop, with immediate review by their treating clinical team, or nearest emergency department or medical practitioner with phone contact to treating team if most practical.
Immune Globulin Intravenous
Biological/VaccineParticipants will continue treatment with their current Ig replacement schedule. Participants will receive monthly (every 4 weeks ± 1 week) intravenous immunoglobulin at a dose of 0.4g/kg, modified to achieve an IgG trough level of at least lower limit of age-specific serum IgG reference range. For patients who have already had their Ig dose titrated to IgG trough level, they may continue on their current monthly dose of Ig replacement. SCIg, weekly, may be used in patients who meet local criteria for home-based self-administration in centres with established SCIg programs. Dosing is usually given at 100mg/kg/week, modified to achieve an IgG steady state level of at least the lower limit of the serum reference range.
Treatment groups
900 Participants
are divided into 3 treatment groupsGroup A: Arm A: Stop Ig and commence prophylactic oral antibioticsOther 1 intervention
Group B: Arm B: Stop IgOther 1 intervention
Group C: Arm C: Continue IgOther 1 intervention
Trial outcomes
Primary outcomes
1
Event-free survival (EFS).
Defined as time from randomisation (or, in domains with a single treatment arm, time from registration) 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 (or, in domains with a single treatment arm, time from registration).Secondary outcomes
1
Occurrence of at least one Grade 3 or higher infection(s) from randomisation to 12 months.
Occurrence of at least one Grade 3 or higher infection(s) from randomisation to 12 months
Time frame
12 months following randomisation (or, in domains with a single treatment arm, time from registration).2
Occurrence of one or more clinically documented infections (symptoms/signs of infection requiring antimicrobial treatment) from randomisation to 12 months.
Occurrence of one or more clinically documented infections (symptoms/signs of infection requiring antimicrobial treatment) from randomisation to 12 months.
Time frame
12 months following randomisation (or, in domains with a single treatment arm, time from registration).3
Number of clinically documented infections (symptoms/signs of infection requiring antimicrobial treatment) from randomisation to 12 months.
Number of clinically documented infections (symptoms/signs of infection requiring antimicrobial treatment) from randomisation to 12 months.
Time frame
12 months following randomisation (or, in domains with a single treatment arm, time from registration).4
Occurrence of one or more microbiologically documented infections from randomisation to 12 months.
Occurrence of one or more microbiologically documented infections from randomisation to 12 months.
Time frame
12 months following randomisation (or, in domains with a single treatment arm, time from registration).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov