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

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

900

Participants

Timeline

Start Date

May 6, 2025

Primary Completion Date

March 31, 2027

Study Completion Date

March 31, 2027

Conditions
MyelomaLeukemiaNon Hodgkin's Lymphoma
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.

DRUG

Amoxycillin/clavulanic acid

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.

BIOLOGICAL

Immune Globulin Intravenous

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.

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