BridgeMD
Oral Alternative Antibiotics for Patients with Syphilis
EU CTIS ID: 2024-514984-24-00
What this study is testing
To demonstrate the non-inferiority of LZD treatment compared with standard BPG treatment to cure patients with early syphilis.
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Aged 18 years or older at baseline visit.
- Primary, secondary or early latent syphilis diagnosis based on SEIMC/IUSTI Guidelines*. a. Primary syphilis is defined as typical ulcer (chancre) and positive test using darkfield examination (DFE) or Polymerase chain reaction (PCR) detection of T.p. with/without positive serological test for syphilis. b. Secondary syphilis is defined based on typical clinical symptoms with positive treponemal and non-treponemal tests. c. Early latent syphilis is defined as positive serological treponemal and non-treponemal tests with no clinical evidence of infection, with a previous negative syphilis serology, or a four-fold increase in RPR titer of a non-treponemal test within the past 12 months. Serological tests for syphilis performed within 10 days prior to study inclusion visit will be acceptable for enrollment.
- Signature of written informed consent.
- Ability to comply with the requirements of the study protocol.
- If women of childbearing potential, use of a highly effective method of contraception (abstinence, hormonal contraception, intra-uterine device [IUD], or anatomical sterility in self or partner) committed during 1 week after last IMP administration.
- If men, use of condom during heterosexual intercourse and use of a highly effective method of contraception (abstinence, hormonal contraception, intra-uterine device [IUD], or anatomical sterility in self or partner) in female partner committed during 1 week after last IMP administration.
You likely can't join if
- Known allergy to any of the IMPs and/or excipients, particularly known hypersensitivity to penicillin, cephalosporins or other beta-lactam agents and/or allergy to soya or peanut.
- Having received treatment for the early syphilis recently diagnosed.
- Lactose or galactose intolerance or glucose-galactose malabsorbtion
- Diagnosis criteria of symptomatic neurosyphilis.
- Pregnant or breastfeeding women
- Current treatment with any drugs likely to interact with the study medication
See the full eligibility criteria
Who can join
- Aged 18 years or older at baseline visit.
- Primary, secondary or early latent syphilis diagnosis based on SEIMC/IUSTI Guidelines*. a. Primary syphilis is defined as typical ulcer (chancre) and positive test using darkfield examination (DFE) or Polymerase chain reaction (PCR) detection of T.p. with/without positive serological test for syphilis. b. Secondary syphilis is defined based on typical clinical symptoms with positive treponemal and non-treponemal tests. c. Early latent syphilis is defined as positive serological treponemal and non-treponemal tests with no clinical evidence of infection, with a previous negative syphilis serology, or a four-fold increase in RPR titer of a non-treponemal test within the past 12 months. Serological tests for syphilis performed within 10 days prior to study inclusion visit will be acceptable for enrollment.
- Signature of written informed consent.
- Ability to comply with the requirements of the study protocol.
- If women of childbearing potential, use of a highly effective method of contraception (abstinence, hormonal contraception, intra-uterine device [IUD], or anatomical sterility in self or partner) committed during 1 week after last IMP administration.
- If men, use of condom during heterosexual intercourse and use of a highly effective method of contraception (abstinence, hormonal contraception, intra-uterine device [IUD], or anatomical sterility in self or partner) in female partner committed during 1 week after last IMP administration.
What rules you out
- Known allergy to any of the IMPs and/or excipients, particularly known hypersensitivity to penicillin, cephalosporins or other beta-lactam agents and/or allergy to soya or peanut.
- Having received treatment for the early syphilis recently diagnosed.
- Lactose or galactose intolerance or glucose-galactose malabsorbtion
- Diagnosis criteria of symptomatic neurosyphilis.
- Pregnant or breastfeeding women
- Current treatment with any drugs likely to interact with the study medication
- Have taken any antibiotics with potential activity against syphilis (e.g. beta lactams, cephalosporines, macrolides, tetracyclines) within 1 week prior to randomization.
- Uncontrolled hypertension, pheochromocytoma, thyrotoxicosis, carcinoid syndrome, bipolar disorder, incapacitating psycho-affective disturbance, acute confusional state.
- Renal function impairment requiring hemodialysis.
- Symptomatic concomitant STI (i.e., gonococcus, chlamydia, lymphogranuloma venereum, Mycoplasma genitalium) or other infection disease requiring antibiotic treatment potentially active against syphilis.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.