Study intervention
ADVERSE EVENTS, RECRUITMENT, SKIN NECROSIS
Participants received a single SC infusion of 3.6 (2,700 mg, 9 mL), 7.2 (5,400 mg, 13.8 mL), or 10.8 MIU (8,100 mg, 20.7 mL) of BPG (Bicillin L-A, Pfizer, Sydney, Australia) delivered under ultrasound guidance. To achieve sustained plasma penicillin concentrations of 73% and 99% for a 3-month period above target concentrations of 20 ng/mL and 10 ng/mL, respectively, we chose a maximal dose of 10.8 MIU BPG (nine vials) (Assignment to treatment was by recruitment order and BMI group ensuring equal BMI representation in each cohort. An independent SMC was appointed to review the safety of study procedures and all adverse events 72 hours after dosing, to approve progression to the next cohort. In particular, skin necrosis at the injection site, which has been reported following SC infusion of other antibiotics (