Overview Study details Eligibility Things to know Research Study plan

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Overview Study details Eligibility Things to know Research Study plan

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

PHASE2PHASE3RECRUITING

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.

Study details:

This is a domain within the RATIONAL Platform Trial to test the effectiveness and safety of prophylactic antibiotics as an alternative Ig replacement in patients who have not yet commenced Ig replacement therapy.

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

Exclusion criteria

Prior or planned allogeneic haematopoietic stem cell transplantation.
Already receiving systemic antibiotic prophylaxis for the purpose of preventing bacterial infection (NB: patients may receive antiviral, antifungal and PJP prophylaxis).
Received immunoglobulin replacement in the preceding three months.
Objection to receiving immunoglobulin products.
Known history of IgA deficiency with anti-IgA.
History of severe allergy to immunoglobulin products.
Current active infection requiring systemic antibiotics.
Allergy or intolerance of all domain antibiotic options.
Pregnant or breastfeeding.
Severe renal impairment (estimated or measured creatinine clearance of < 30 mL/min).
Previous splenectomy.
Previous participation in this domain.
Treating team deems enrolment in the domain is not in the best interest of the patient.

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

Study type

TREATMENT

Phase

PHASE2PHASE3

Study ID

NCT07202078

Intervention or treatment

DRUG: Trimethoprim / Sulfamethoxazole

BIOLOGICAL: Immune Globulin Intravenous

Conditions

Myeloma
Non Hodgkin's Lymphoma
Leukemia

Condition: Myeloma, Non Hodgkin's Lymphoma and more
DRUG: Trimethoprim / Sulfamethoxazole and other drugs
Adelaide, South Australia, Australia and more
Sponsor: Monash University

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You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial?

If you're a clinic or sponsor, you can claim this study

Research sites nearby

Closest Location:

Royal Adelaide Hospital

Select from list below to view details:

Royal Adelaide Hospital
Adelaide, South Australia, Australia
Austin Hospital
Melbourne, Victoria, Australia
Northern Health
Melbourne, Victoria, Australia

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Who is running the clinical trial?

Monash University

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
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.	Drug: Trimethoprim / Sulfamethoxazole
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.	Biological: Immune Globulin Intravenous

Participant Group/Arm

Intervention/Treatment

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.

Drug: Trimethoprim / Sulfamethoxazole

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.

Biological: Immune Globulin Intravenous

What is the study measuring?

Primary Outcome

Measure	Description	Time Frame
Event-free survival (EFS).	Defined as time from randomisation (or, in domains with a single treatment arm, time from registration) until occurrence of a Grade 3 or higher infection (as defined by CTCAE Version 5), or death from any cause.	12 months following randomisation (or, in domains with a single treatment arm, time from registration).

Secondary Outcome

Measure	Description	Time Frame
Occurrence of at least one Grade 3 or higher infection(s) from randomisation to 12 months.	Occurrence of at least one Grade 3 or higher infection(s) from randomisation to 12 months.	12 months following randomisation (or, in domains with a single treatment arm, time from registration).
Occurrence of one or more clinically documented infections (symptoms/signs of infection requiring antimicrobial treatment) from randomisation to 12 months.	Occurrence of one or more clinically documented infections (symptoms/signs of infection requiring antimicrobial treatment) from randomisation to 12 months.	12 months following randomisation (or, in domains with a single treatment arm, time from registration).
Number of clinically documented infections (symptoms/signs of infection requiring antimicrobial treatment) from randomisation to 12 months.	Number of clinically documented infections (symptoms/signs of infection requiring antimicrobial treatment) from randomisation to 12 months.	12 months following randomisation (or, in domains with a single treatment arm, time from registration).
Occurrence of one or more microbiologically documented infections from randomisation to 12 months.	Occurrence of one or more microbiologically documented infections from randomisation to 12 months.	12 months following randomisation (or, in domains with a single treatment arm, time from registration).
Number of microbiologically documented infections from randomisation to 12 months.	Number of microbiologically documented infections from randomisation to 12 months.	12 months following randomisation (or, in domains with a single treatment arm, time from registration).
All-cause mortality at 12 months.	All-cause mortality at 12 months.	12 months following randomisation (or, in domains with a single treatment arm, time from registration).
Infection-related mortality at 12 months.	Infection-related mortality at 12 months.	12 months following randomisation (or, in domains with a single treatment arm, time from registration).
Time free from hospitalisation with antimicrobial administration with therapeutic intent from randomisation to 12 months.	Time free from hospitalisation with antimicrobial administration with therapeutic intent from randomisation to 12 months.	12 months following randomisation (or, in domains with a single treatment arm, time from registration).
Occurrence of one or more treatment-related adverse events.	Occurrence of one or more treatment-related adverse events.	12 months following randomisation (or, in domains with a single treatment arm, time from registration).
Number of treatment-related adverse events.	Number of treatment-related adverse events.	12 months following randomisation (or, in domains with a single treatment arm, time from registration).
Isolation of fluoroquinolone resistant organisms, co-trimoxazole resistant organisms, extended spectrum beta lactamases or multidrug resistant organisms from randomisation to 12 months.	Isolation of fluoroquinolone resistant organisms, co-trimoxazole resistant organisms, extended spectrum beta lactamases or multidrug resistant organisms from randomisation to 12 months.	12 months following randomisation (or, in domains with a single treatment arm, time from registration).
Number of infections with fluoroquinolone resistant organisms, co-trimoxazole resistant organisms, extended spectrum beta lactamases or multidrug resistant organisms isolated from randomisation to 12 months.	Number of infections with fluoroquinolone resistant organisms, co-trimoxazole resistant organisms, extended spectrum beta lactamases or multidrug resistant organisms isolated from randomisation to 12 months.	12 months following randomisation (or, in domains with a single treatment arm, time from registration).
Quality of Life (QoL) measured at randomisation then 3, 6, 9 and 12 months, using different questionnaire.	Quality of Life (QoL) measured at randomisation then 3, 6, 9 and 12 months, using different questionnaire.	Randomisation, Month 3, Month 6, Month 9 and Month 12.
Costs associated with allocated treatment arm and infections during study.	Costs of infections and trial interventions will be estimated based on trial treatment and adverse event data within the hospital medical record, as well as linked data obtained from the Medicare Benefits Scheme (MBS), Pharmaceutical Benefits Scheme (PBS) and Australian Immunisation Register (AIR). Data from the quality of life questionnaires will be used to calculate quality adjusted life years.	12 months following randomisation (or, in domains with a single treatment arm, time from registration).

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References

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

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