Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy (Stop-Ig)

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Australia
Royal Adelaide Hospital
RECRUITING
Adelaide
Austin Hospital
RECRUITING
Melbourne
Northern Health
RECRUITING
Melbourne
Time Frame
Start Date: 2025-05-06
Estimated Completion Date: 2027-03-31
Participants
Target number of participants: 900
Treatments
Other: Arm A: Stop Ig and commence prophylactic oral antibiotics
Once daily trimethoprim-sulfamethoxazole (co-trimoxazole) 160mg/800mg. NB: Doxycycline 100mg daily as an alternative for patients with hypersensitivity to co-trimoxazole.
Other: Arm B: Stop Ig
Patients 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.~NB: Clindamycin 600 mg is permitted as an alternative to amoxycillin/clavulanic acid for patients with hypersensitivity to penicillin. Ciprofloxacin is omitted for participants with hypersensitivity.
Other: Arm C: Continue Ig
Participants 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.
Related Therapeutic Areas
Sponsors
Leads: Monash University

This content was sourced from clinicaltrials.gov