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

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

900

Participants

Timeline

Start Date

May 7, 2025

Primary Completion Date

March 31, 2027

Study Completion Date

March 31, 2027

Conditions
MyelomaNon Hodgkin's LymphomaLeukemia
Interventions
DRUG

Trimethoprim / Sulfamethoxazole

Once daily trimethoprim-sulfamethoxazole (co-trimoxazole) 160mg/800mg. NB: Doxycycline 100mg daily as an alternative for patients with hypersensitivity to co-trimoxazole.

BIOLOGICAL

Immune Globulin Intravenous

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.

Trial Locations (3)

3004

RECRUITING

Austin Hospital, Melbourne

RECRUITING

Northern Health, Melbourne

5000

RECRUITING

Royal Adelaide Hospital, Adelaide

All Listed Sponsors
lead

Monash University

OTHER