Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
A database of clinical trials and their results from Australia, New Zealand, and other countries.
account_circle
Log in
to register or update your trial
search
Search for trials
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12624001383550
Ethics application status
Approved
Date submitted
24/10/2024
Date registered
21/11/2024
Date last updated
2/02/2025
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
Query!
Scientific title
Subcutaneous injections of benzathine penicillin G (SCIP) for rheumatic heart disease in Maningrida
Query!
Secondary ID [1]
313247
0
Nil
Query!
Universal Trial Number (UTN)
U1111-1313-9092
Query!
Trial acronym
SCIP - Maningrida
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Rheumatic fever
335564
0
Query!
Rheumatic heart disease
335565
0
Query!
Condition category
Condition code
Cardiovascular
332136
332136
0
0
Query!
Other cardiovascular diseases
Query!
Infection
332308
332308
0
0
Query!
Other infectious diseases
Query!
Intervention/exposure
Study type
Interventional
Query!
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).
Query!
Intervention code [1]
329826
0
Prevention
Query!
Intervention code [2]
329827
0
Treatment: Drugs
Query!
Comparator / control treatment
No control group
Query!
Control group
Uncontrolled
Query!
Outcomes
Primary outcome [1]
339711
0
The acceptability of SCIP implementation
Query!
Assessment method [1]
339711
0
Qualitative (thematic) analysis of stakeholder interviews. Purposive sampling of stakeholders will ensure that broad perspectives are represented across people living with RHD, their caregivers, community members, healthcare workers and public health stakeholders.
Query!
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.
Query!
Primary outcome [2]
339712
0
Intention to continue receiving SCIP as rheumatic heart disease (RHD) prophylaxis once the study period ends.
Query!
Assessment method [2]
339712
0
The number and proportion of participants who, in their final post-SCIP survey, report an intention to continue using SCIP as secondary prophylaxis once the study period ends.
Query!
Timepoint [2]
339712
0
Immediately after the participant's final SCIP administration in the study period.
Query!
Primary outcome [3]
339713
0
The safety and self-reported tolerability of SCIP administration
Query!
Assessment method [3]
339713
0
No. and severity of adverse events reported that are related to SCIP implementation, self-reported tolerability scores using the Faces Pain Scale.
Query!
Timepoint [3]
339713
0
48-weeks following the first participant's first SCIP administration
Query!
Secondary outcome [1]
440984
0
The proportion of participants who receive >80% of the recommended SCIP administrations during the study period
Query!
Assessment method [1]
440984
0
Descriptive analyses of SCIP uptake data from patient medical records
Query!
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)
Query!
Secondary outcome [2]
440985
0
The frequency of adverse events that are causally related to SCIP administration
Query!
Assessment method [2]
440985
0
Adverse events will be detected on clinical examination and from participant self-reporting. Root cause analysis of reported adverse events will determine causality.
Query!
Timepoint [2]
440985
0
Baseline and daily until the end of the study period (48 weeks post initial dose)
Query!
Secondary outcome [3]
441511
0
Plasma penicillin concentration
Query!
Assessment method [3]
441511
0
Dried blood spot assays using fingerprick sampling
Query!
Timepoint [3]
441511
0
4-8 weeks post-SCIP dose and immediately before the next BPG dose
Query!
Secondary outcome [4]
441512
0
ARF recurrence
Query!
Assessment method [4]
441512
0
Detected using routinely collected clinic data and RHD patient register data
Query!
Timepoint [4]
441512
0
At baseline and daily until the end of the study period (48 weeks post initial dose)
Query!
Secondary outcome [5]
441513
0
BPG adherence
Query!
Assessment method [5]
441513
0
Comparison of the proportion of recommended BPG doses received pre-SCIP and during SCIP implementation
Query!
Timepoint [5]
441513
0
At the end of the study period (48 weeks post initial dose)
Query!
Secondary outcome [6]
441773
0
Changes in cardiac status
Query!
Assessment method [6]
441773
0
Detected using routinely collected clinic data and RHD patient register data
Query!
Timepoint [6]
441773
0
At the end of the study period (48 weeks post initial dose)
Query!
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.
Query!
Minimum age
No limit
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Not yet recruiting
Query!
Date of first participant enrolment
Anticipated
17/02/2025
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
27/10/2025
Query!
Actual
Query!
Date of last data collection
Anticipated
19/01/2026
Query!
Actual
Query!
Sample size
Target
20
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NT
Query!
Funding & Sponsors
Funding source category [1]
317690
0
Government body
Query!
Name [1]
317690
0
Australian Government Medical Research Future Fund
Query!
Address [1]
317690
0
Query!
Country [1]
317690
0
Australia
Query!
Primary sponsor type
Charities/Societies/Foundations
Query!
Name
The Kids Research Institute Australia
Query!
Address
Query!
Country
Australia
Query!
Secondary sponsor category [1]
320012
0
None
Query!
Name [1]
320012
0
Query!
Address [1]
320012
0
Query!
Country [1]
320012
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
316387
0
NT Health and Menzies School of Health Research Human Research Ethics Committee
Query!
Ethics committee address [1]
316387
0
https://health.nt.gov.au/data-and-research/nt-health-research/research-ethics
Query!
Ethics committee country [1]
316387
0
Australia
Query!
Date submitted for ethics approval [1]
316387
0
06/11/2024
Query!
Approval date [1]
316387
0
19/12/2024
Query!
Ethics approval number [1]
316387
0
Query!
Summary
Brief summary
People living with rheumatic heart disease are often recommended to have antibiotic injections at least every 28-days over five years to reduce their risk of permanent heart damage. Our team has developed a new, less painful, way to provide these antibiotics, called ‘SCIP’, which provides 10-weeks of protection. By partnering with the Mala'la Aboriginal Health Service Corporation we will offer SCIP to people in need of regular BPG in Maningrida, Northern Territory, Australia and evaluate how well it works for them, with the ultimate goal of using SCIP to lengthen life, reduce illness and disability from rheumatic heart disease. We hypothesize that SCIP will provide an acceptable alternative way for people to get their regular BPG.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
137738
0
A/Prof Laurens Manning
Query!
Address
137738
0
The Kids Research Institute Australia, Northern Entrance, Perth Children's Hospital, 15 Hospital Avenue, NEDLANDS Western Australia 6009
Query!
Country
137738
0
Australia
Query!
Phone
137738
0
+61 8 6319 1456
Query!
Fax
137738
0
Query!
Email
137738
0
[email protected]
Query!
Contact person for public queries
Name
137739
0
Jane Oliver
Query!
Address
137739
0
The Kids Research Institute Australia, Northern Entrance, Perth Children's Hospital, 15 Hospital Avenue, NEDLANDS Western Australia 6009
Query!
Country
137739
0
Australia
Query!
Phone
137739
0
+61 8 6319 1000
Query!
Fax
137739
0
Query!
Email
137739
0
[email protected]
Query!
Contact person for scientific queries
Name
137740
0
Jane Oliver
Query!
Address
137740
0
The Kids Research Institute Australia, Northern Entrance, Perth Children's Hospital, 15 Hospital Avenue, NEDLANDS Western Australia 6009
Query!
Country
137740
0
Australia
Query!
Phone
137740
0
+61 8 6319 1000
Query!
Fax
137740
0
Query!
Email
137740
0
[email protected]
Query!
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.
Download to PDF