None listed
Conditions
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.
Interventions
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 par
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).
Sponsors
The Kids Research Institute Australia
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Healthy volunteers
No
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.
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.
Outcome results
None listed