Alternative Antibiotics for Syphilis (NCT05069974) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Alternative Antibiotics for Syphilis
Spain224 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 range18 Years – 99 Years
SexALL
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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.
✓. 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.
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.
✕
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
. 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.