Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000031460p
Ethics application status
Submitted, not yet approved
Date submitted
3/12/2024
Date registered
16/01/2025
Date last updated
16/01/2025
Date data sharing statement initially provided
16/01/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Subcutaneous injections of benzathine penicillin G (SCIP) for rheumatic heart disease in Kununurra
Scientific title
Subcutaneous injections of benzathine penicillin G (SCIP) for rheumatic heart disease in Kununurra
Secondary ID [1] 313517 0
Nil
Universal Trial Number (UTN)
U1111-1316-4224
Trial acronym
SCIP - Kununurra
Linked study record
This study does not relate to ACTRN12624001383550 "SCIP - Maningrida" or to ACTRN12624000333516 "SCIP RHD"
While the aims and methods for these studies are similar, they are separate clinical trials.

Health condition
Health condition(s) or problem(s) studied:
Rheumatic fever 335951 0
Rheumatic heart disease 335950 0
Condition category
Condition code
Cardiovascular 332540 332540 0 0
Other cardiovascular diseases
Infection 332541 332541 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subcutaneous injections of benzathine penicillin G (termed 'SCIP') will be offered as an alternative to the current standard of care for secondary prophylaxis, which involves regular deep intramuscular injections of benzathine penicillin G (BPG).

SCIP will be offered to participants at 10-week intervals. SCIP will be administered by healthcare workers at Ord Valley Aboriginal Health Service (OVAHS). The study period is 48-weeks. Each participant will have a minimum follow-up period of 12-weeks. Consequently participants will be offered a maximum of 5 SCIP doses and a minimum of 2 doses, depending on what point they were recruited at.

The drug administered is BPG: Bicillin® L-A (Pfizer).
Each vial contains 1.2MU BPG.
The dose depends on the participant body weight.
Participants <20kgs will receive 4 vials of Bicillin® L-A (9.2mL), those 20-<30kg receive 5 vials (11.5mL), those 30-<60kg receive 7 vials (13.8mL), and those weighing 60+ kg receive 9 vials (20.7mL).

BPG uptake via IM/SCIP will be monitored through reviewing participants' clinic records.
Intervention code [1] 330092 0
Prevention
Intervention code [2] 330093 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340059 0
The acceptability of SCIP implementation
Timepoint [1] 340059 0
Qualitative data collection will occur at pre-SCIP eligibility screening, post-SCIP eligibility screening, post-consent for SCIP but pre SCIP administration, in the week after the first SCIP administration and at 10-12 weeks post-SCIP administration. This sampling schedule enables possible improvements to SCIP implementation to be identified at each stage of the SCIP participant journey. Purposive sampling will result in some participants being interviewed at multiple time points.
Primary outcome [2] 340060 0
The self-reported tolerability of SCIP administration
Timepoint [2] 340060 0
Immediately post SCIP administration
Primary outcome [3] 340061 0
Intention to continue receiving SCIP as rheumatic heart disease (RHD) prophylaxis once the study period ends.
Timepoint [3] 340061 0
Immediately after the participant's final SCIP administration in the study period.
Secondary outcome [1] 442514 0
Changes in cardiac status
Timepoint [1] 442514 0
At the end of the study period (48 weeks post initial dose)
Secondary outcome [2] 442511 0
Acute rheumatic fever recurrence
Timepoint [2] 442511 0
At baseline and daily until the end of the study period (48 weeks post initial dose)
Secondary outcome [3] 442509 0
BPG adherence
Timepoint [3] 442509 0
At the end of the study period (48 weeks post initial dose)
Secondary outcome [4] 442513 0
Plasma penicillin concentration
Timepoint [4] 442513 0
4-8 weeks post-SCIP dose and immediately before the next BPG dose
Secondary outcome [5] 442510 0
The frequency of adverse events that are causally related to SCIP administration
Timepoint [5] 442510 0
Baseline and daily until the end of the study period (48 weeks post initial dose)
Secondary outcome [6] 442512 0
The proportion of participants who receive >80% of the recommended SCIP administrations during the study period
Timepoint [6] 442512 0
At the Initial Progress Review (predicted in April 2025), and at the end of the study period (48-weeks following the first SCIP administration)

Eligibility
Key inclusion criteria
Provide informed consent to participate (or informed assent to receive SCIP with a caregiver's informed consent if aged <15 years)
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Excluded from receiving SCIP are those who have:
• Never had IM BPG through OVAHS to prevent acute rheumatic fever recurrence.
• Anticipated to be unavailable for one or more of the recommended SCIP administrations during the follow-up period
• Unwilling to undergo height, weight, and vital sign assessments prior to receiving SCIP
• History of adverse drug reaction/hypersensitivity/allergy to penicillin.
• Pregnancy (self-reported)
• Extensive scarring or dermatological conditions affecting skin integrity at the intended site of SCIP administration
• Are unable to contact clinic staff following SCIP administration if they have safety concerns.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/02/2025
Actual
Date of last participant enrolment
Anticipated
27/10/2025
Actual
Date of last data collection
Anticipated
19/01/2026
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 317969 0
Charities/Societies/Foundations
Name [1] 317969 0
Wesfarmers Centre of Vaccines & Infectious Diseases
Country [1] 317969 0
Australia
Funding source category [2] 317966 0
Government body
Name [2] 317966 0
Australian Government Department of Health and Aged Care - Medical Research Future Fund
Country [2] 317966 0
Australia
Funding source category [3] 317968 0
Government body
Name [3] 317968 0
WA Child Research Fund
Country [3] 317968 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
The Kids Research Institute Australia
Address
Country
Australia
Secondary sponsor category [1] 320307 0
None
Name [1] 320307 0
Address [1] 320307 0
Country [1] 320307 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316638 0
Western Australian Aboriginal Health Ethics Committee
Ethics committee address [1] 316638 0
Ethics committee country [1] 316638 0
Australia
Date submitted for ethics approval [1] 316638 0
30/10/2024
Approval date [1] 316638 0
Ethics approval number [1] 316638 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 138498 0
A/Prof Laurens Manning
Address 138498 0
The Kids Research Institute Australia, Northern Entrance, Perth Children's Hospital, 15 Hospital Avenue, NEDLANDS Western Australia 6009
Country 138498 0
Australia
Phone 138498 0
+61 8 6319 1456
Fax 138498 0
Email 138498 0
[email protected]
Contact person for public queries
Name 138499 0
Jane Oliver
Address 138499 0
The Kids Research Institute Australia, Northern Entrance, Perth Children's Hospital, 15 Hospital Avenue, NEDLANDS Western Australia 6009
Country 138499 0
Australia
Phone 138499 0
+61 8 6319 1000
Fax 138499 0
Email 138499 0
[email protected]
Contact person for scientific queries
Name 138500 0
Jane Oliver
Address 138500 0
The Kids Research Institute Australia, Northern Entrance, Perth Children's Hospital, 15 Hospital Avenue, NEDLANDS Western Australia 6009
Country 138500 0
Australia
Phone 138500 0
+61 8 6319 1000
Fax 138500 0
Email 138500 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Participant privacy is paramount



What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.