Phase 3 study

Recruiting Phase 3

Sources: ClinicalTrials.gov Checked: 11 October 2026 Not medical advice

This trial at a glance

Status Recruiting
Phase Phase 3
Sponsor Monash University
Registry number NCT07202078
Started 7 May 2025 Today 16 October 2026 Estimated completion 31 March 2027

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
Royal Adelaide Hospital Adelaide SA Recruiting
Austin Hospital Melbourne VIC Recruiting
Northern Health Melbourne VIC Recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice

Who can join

Age 18 Years and over
Sex Anyone, regardless of sex
Healthy volunteers Not accepted
Enrolment target 900

The official eligibility criteria

Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.

Inclusion Criteria:

* None.

Exclusion Criteria:

1. Prior or planned allogeneic haematopoietic stem cell transplantation.

2. Already receiving systemic antibiotic prophylaxis for the purpose of preventing bacterial infection (NB: patients may receive antiviral, antifungal and PJP prophylaxis).

3. Received immunoglobulin replacement in the preceding three months.

4. Objection to receiving immunoglobulin products.

5. Known history of IgA deficiency with anti-IgA.

6. History of severe allergy to immunoglobulin products.

7. Current active infection requiring systemic antibiotics.

8. Allergy or intolerance of all domain antibiotic options.

9. Pregnant or breastfeeding.

10. Severe renal impairment (estimated or measured creatinine clearance of \< 30 mL/min).

11. Previous splenectomy.

12. Previous participation in this domain.

13. Treating team deems enrolment in the domain is not in the best interest of the patient.

Dates on the record

Started 7 May 2025
Estimated completion 31 March 2027
Registry last updated 7 October 2025
Checked by Voxsanity 11 October 2026

Results, publications and the official record

Sources and dates

  • ClinicalTrials.gov – the record this page reformats
  • ClinicalTrials.gov processing date: 7 October 2025.
  • This page last checked by Voxsanity: 11 October 2026.

Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.

Not medical advice.

Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.

Letter for your doctor

A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.