Alternative Antibiotics for Syphilis

Launched by FUNDACIÓN FLS DE LUCHA CONTRA EL SIDA, LAS ENFERMEDADES INFECCIOSAS Y LA PROMOCIÓN DE LA SALUD Y LA CIENCIA · Oct 5, 2021

Keywords

ClinConnect Summary

The Trep-AB clinical trial is studying a new treatment for early syphilis using a drug called Linezolid, which is different from the usual treatment, Benzathine penicillin G. The goal is to see if Linezolid can effectively treat early stages of syphilis, including primary, secondary, and early latent syphilis. This trial is currently looking for participants aged 18 and older who have been diagnosed with these types of syphilis. To join, individuals must be able to provide informed consent and meet specific health criteria.

Participants in this trial can expect to receive either the new medication or the standard treatment and will be monitored throughout the study. It’s important to note that women who can become pregnant and men must use effective birth control methods during and after the study to prevent pregnancy. Additionally, individuals with certain medical conditions or those currently taking specific medications may not qualify for the trial. This study aims to find out if Linezolid could be a viable alternative treatment for early syphilis, which could benefit many patients in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 18 years or older at baseline visit.
• • 2. Primary, secondary or early latent syphilis diagnosis based on SEIMC/IUSTI Guidelines\*
• • 1. 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.
• • 2. Secondary syphilis is defined based on typical clinical symptoms with positive treponemal and non-treponemal tests.
• • 3. 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.
• • 3. Signature of written informed consent.
• • 4. Ability to comply with the requirements of the study protocol.
• • 5. 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.
• • 6. If men, use of condom during heterosexual intercourse and use of a highly effective method ofcontraception (abstinence, hormonal contraception, intra-uterine device \[IUD\], or anatomical sterilityin self or partner) in female partner committed during 1 week after last IMP administration.
• • For inclusion purposes, positive point of care tests (POCT) will be accepted in selected patients without previous syphilis history and negative serological tests for syphilis during the last 12 months (Syphilis rapid diagnostic test \[RDT\] or Chembio DPP syphilis screen \& confirm assay \[DPP\]), or with a previous history of syphilis and negative non-treponemal tests during the last 12 months (DPP). Further confirmation by the methods described in a), b) or c) will benecessary.
• Exclusion Criteria:
• • 1. 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.
• • 2. Lactose or galactose intolerance or glucose-galactose malabsorbtion.
• • 3. Diagnosis criteria of symptomatic neurosyphilis.
• • 4. Pregnant or breastfeeding women.
• • 5. Current treatment with any drugs likely to interact with the study medication (see Appendix 6).
• • 6. Have taken any antibiotics with potential activity against syphilis (e.g. beta lactams, cephalosporines, macrolides, tetracyclines) within 1 week prior to randomization.
• • 7. Uncontrolled hypertension, pheochromocytoma, thyrotoxicosis, carcinoid syndrome, bipolar disorder, incapacitating psycho-affective disturbance, acute confusional state.
• • 8. Renal function impairment requiring hemodialysis.
• • 9. Symptomatic concomitant STI (i.e., gonococcus, chlamydia, lymphogranuloma venereum, Mycoplasma genitalium) or other infection disease requiring antibiotic treatment potentially active against syphilis.
• • 10. Having received treatment for the early syphilis recently diagnosed (In the previous 6 months)