'One injection vs. three': Clinical evaluation of a single, high dose subcutaneous infusion of benzathine penicillin G for treatment of syphilis (SCIP Syphilis)
- Conditions
- SyphilisInfection - Sexually transmitted infectionsInfection - Studies of infection and infectious agents
- Registration Number
- ACTRN12622000349741
- Lead Sponsor
- South Metropolitan Health Service
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
(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.
(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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method