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Trial registered on ANZCTR


Registration number
ACTRN12624001383550p
Ethics application status
Submitted, not yet approved
Date submitted
24/10/2024
Date registered
21/11/2024
Date last updated
21/11/2024
Date data sharing statement initially provided
21/11/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Subcutaneous injections of benzathine penicillin G (SCIP) for rheumatic heart disease in Maningrida
Scientific title
Subcutaneous injections of benzathine penicillin G (SCIP) for rheumatic heart disease in Maningrida
Secondary ID [1] 313247 0
Nil
Universal Trial Number (UTN)
U1111-1313-9092
Trial acronym
SCIP - Maningrida
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatic fever 335564 0
Rheumatic heart disease 335565 0
Condition category
Condition code
Cardiovascular 332136 332136 0 0
Other cardiovascular diseases
Infection 332308 332308 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.

SCIP will be offered to participants at 10-week intervals. SCIP will be administered by healthcare workers at Mala'la Aboriginal Health Service. 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 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).
Intervention code [1] 329826 0
Prevention
Intervention code [2] 329827 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339711 0
The acceptability of SCIP implementation
Timepoint [1] 339711 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] 339712 0
Intention to continue receiving SCIP as rheumatic heart disease (RHD) prophylaxis once the study period ends.
Timepoint [2] 339712 0
Immediately after the participant's final SCIP administration in the study period.
Primary outcome [3] 339713 0
The safety and self-reported tolerability of SCIP administration
Timepoint [3] 339713 0
48-weeks following the first participant's first SCIP administration
Secondary outcome [1] 440984 0
The proportion of participants who receive >80% of the recommended SCIP administrations during the study period
Timepoint [1] 440984 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)
Secondary outcome [2] 440985 0
The frequency of adverse events that are causally related to SCIP administration
Timepoint [2] 440985 0
Baseline and daily until the end of the study period (48 weeks post initial dose)
Secondary outcome [3] 441511 0
Plasma penicillin concentration
Timepoint [3] 441511 0
4-8 weeks post-SCIP dose and immediately before the next BPG dose
Secondary outcome [4] 441512 0
ARF recurrence
Timepoint [4] 441512 0
At baseline and daily until the end of the study period (48 weeks post initial dose)
Secondary outcome [5] 441513 0
BPG adherence
Timepoint [5] 441513 0
At the end of the study period (48 weeks post initial dose)
Secondary outcome [6] 441773 0
Changes in cardiac status
Timepoint [6] 441773 0
At the end of the study period (48 weeks post initial dose)

Eligibility
Key inclusion criteria
Provide informed consent to participate (or informed assent to receive SCIP with a caregiver's informed consent if aged <16 years),
and
have received intramuscular BPG as secondary prophylaxis for RHD at the Mala'la clinic, and be able to receive SCIP safely.
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 Mala'la as secondary prophylaxis for RHD
• 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)
NT

Funding & Sponsors
Funding source category [1] 317690 0
Government body
Name [1] 317690 0
Australian Government Medical Research Future Fund
Country [1] 317690 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
The Kids Research Institute Australia
Address
Country
Australia
Secondary sponsor category [1] 320012 0
None
Name [1] 320012 0
Address [1] 320012 0
Country [1] 320012 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316387 0
NT Health and Menzies School of Health Research Human Research Ethics Committee
Ethics committee address [1] 316387 0
Ethics committee country [1] 316387 0
Australia
Date submitted for ethics approval [1] 316387 0
06/11/2024
Approval date [1] 316387 0
Ethics approval number [1] 316387 0

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

Contacts
Principal investigator
Name 137738 0
A/Prof Laurens Manning
Address 137738 0
The Kids Research Institute Australia, Northern Entrance, Perth Children's Hospital, 15 Hospital Avenue, NEDLANDS Western Australia 6009
Country 137738 0
Australia
Phone 137738 0
+61 8 6319 1456
Fax 137738 0
Email 137738 0
laurens.manning@uwa.edu.au
Contact person for public queries
Name 137739 0
Jane Oliver
Address 137739 0
The Kids Research Institute Australia, Northern Entrance, Perth Children's Hospital, 15 Hospital Avenue, NEDLANDS Western Australia 6009
Country 137739 0
Australia
Phone 137739 0
+61 8 6319 1000
Fax 137739 0
Email 137739 0
jane.oliver@thekids.org.au
Contact person for scientific queries
Name 137740 0
Jane Oliver
Address 137740 0
The Kids Research Institute Australia, Northern Entrance, Perth Children's Hospital, 15 Hospital Avenue, NEDLANDS Western Australia 6009
Country 137740 0
Australia
Phone 137740 0
+61 8 6319 1000
Fax 137740 0
Email 137740 0
jane.oliver@thekids.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided 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.