None listed
Conditions
Brief summary
Australia is currently in the midst of a syphilis epidemic which began a decade ago. Benzathine penicillin G (BPG) is the treatment of choice for non-CNS syphilis infections. Primary, secondary or early latent syphilis is treated with 2.4 million units (MU) of BPG, while late latent syphilis requires 2.4 MU weekly for 3 weeks in total. BPG is typically administered by IM injection which is associated with significant pain and distress in the recipient. This has been shown to negatively impact adherence, especially where multiple doses are indicated. Subcutaneous (SC) administration of BPG is a potentially more efficacious alternative to IM injection. Prior work done by our group in healthy adult volunteers have demonstrated acceptable tolerability and a superior pharmacokinetic profile. Our study aims to demonstrate the safety and tolerability of a single 7.2MU dose of BPG given as a subcutaneous infusion for treatment of syphilis. Secondary objectives are to demonstrate efficacy of SC BPG and estimate duration that plasma penicillin concentrations remain above the target of 18mg/mL. Primary outcome is the assessment of safety and tolerability including serious adverse events or reactions. Secondary outcomes are the change in nontreponemal specific serology titre at 6 months, plasma penicillin concentrations at 3 weeks and proportion of patients with treatment failure requiring re-treatment at 6 months. We will recruit 40 adult patients with confirmed syphilis infection from those referred to the sexual health service at Fremantle Hospital. The study will also incorporate a qualitative component exploring patient's experience and perception of receiving subcutaneous infusion. Participants will be followed up for 6 months from day of treatment. If we are successful in demonstrating safety, tolerability and efficacy of SC high dose penicillin in non-CNS syphilis infections, this has the potential to radically transform the treatment paradigm.
Interventions
7.2 MU (13.8mL) benzathine penicillin G (BPG) as Bicillin® L-A given as a single (once-only) subcutaneous infusion (over 10 - 30 minutes) in adults for treatment of non-central nervous system (CNS) syphilis infections.
Sponsors
South Metropolitan Health Service
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(a) Males and non-pregnant females aged older than 18 years (b) Diagnosis of syphilis infection (made by a medical practitioner) AND requiring treatment with BPG in the form of Bicillin® L-A. This is defined as follows: i. Positive treponemal serology (Total antibody AND TPPA) ii. Primary syphilis (diagnosed clinically) with PCR confirmation of T. pallidum (c) No prior documented allergy to penicillin. (d) No history of anaphylactic reaction to cephalosporin antibiotics. (e) Participants who are considered likely to adhere to the trial guidelines for the duration of the trial and are willing and deemed reliable to attend follow up appointments as outlined in the protocol. (f) Able to provide informed consent in accordance with Good Clinical Practice.
Exclusion criteria
(a) Pregnant or breastfeeding females (b) Diagnosis of neurosyphilis (CNS, otic or optic syphilis) made by a medical practitioner (c) Known hypersensitivity or contraindication to use of penicillin. (d) Existing dermatological conditions or other abnormalities (e.g., extensive scarring) that may affect skin integrity at the site of injection, especially abdomen or lateral hips. (e) Presence of significant co-morbidities which is likely to impact patient’s participation the study, as assessed by a medical practitioner
Outcome results
None listed