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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Biological, Drug
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:

• None.

Locations
Other Locations
Australia
Royal Adelaide Hospital
RECRUITING
Adelaide
Austin Hospital
RECRUITING
Melbourne
Northern Health
RECRUITING
Melbourne
Time Frame
Start Date: 2025-05-07
Estimated Completion Date: 2027-03-31
Participants
Target number of participants: 900
Treatments
Other: Arm A: Start 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: Start immunoglobulin replacement
IVIg every 4 weeks ± 1 week 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; or 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. A loading IVIg dose may be given in the first month if required.
Related Therapeutic Areas
Sponsors
Leads: Monash University

This content was sourced from clinicaltrials.gov