Alternative Antibiotics for Syphilis (NCT05069974) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Alternative Antibiotics for Syphilis
Spain, United Kingdom224 participantsStarted 2021-10-14
Plain-language summary
The Trep-AB clinical trial will test the efficacy of an investigational neuropenetrative drug, Linezolid (LZD), compared to standard treatment, Benzathine penicillin G (BPG), for early syphilis in humans. The overarching idea of the work proposed herein is to investigate the use of LZD to treat syphilis, conducting a randomized controlled clinical trial to evaluate this new indication of a known antibacterial agent.
Who can participate
Age range
18 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age 18 years or older at baseline visit.
. Primary, secondary or early latent syphilis diagnosis based on SEIMC/IUSTI Guidelines\*
. 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.
. Secondary syphilis is defined based on typical clinical symptoms with positive treponemal and non-treponemal tests.
. 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 willbe acceptable for enrollment.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of patients with clinical resolution of primary syphilis lesions (clinical cure, primary).
Timeframe: at week 2
2
Proportion of patients with clinical resolution of secondary syphilis lesions (clinical cure, secondary).
Timeframe: at week 6
3
Proportion of patients with adequate serological response (serological cure, week 12).
Timeframe: at week 12
4
Proportion of patients with adequate serological response (serological cure, week 24).
Timeframe: at week 24
5
Proportion of patients with adequate serological response (serological cure, week 48).
Timeframe: at week 48
6
Proportion of patients with allelic variation in T. pallidum strain(s) DNA in recurrent syphilis or suspected treatment failure (molecular cure).
Timeframe: From date of randomization until date of first documented recurrence or treatment failure, assesed up to 48 weeks
Trial details
NCT IDNCT05069974
SponsorFundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
. 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.
Exclusion criteria
. 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.
. 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 Appendix 6).
. Have taken any antibiotics with potential activity against syphilis (e.g. beta lactams, cephalosporines, macrolides, tetracyclines) within 1 week prior to randomization.