Maria Ubals, Martí Vall- Mayans, Oriol Mitjà

Hospital Universitari Germans Trias i Pujol, Badalona, Spain

The epidemic of syphilis is without control worldwide and its management remains a challenge. Current therapeutic options for syphilis are, broadly speaking restricted to one antibiotic, benzathine penicillin G (BPG) which does not efficiently cross the blood-brain barrier. Treponema pallidum (T.p.), the bacterium that causes syphilis, invades the central nervous System (CNS) in about 40% of patients usually without symptoms. The prognostic implications of CNS invasion are the failure to clear organisms, which can lead to serious neurological complications and treatment failure due to bacteria sequestered in the CNS. When indicated, the only way to identify and treat neurosyphilis is by performing a lumbar puncture (LP) to examine cerebrospinal fluid (CSF), followed by therapy with intravenous (IV) benzyl penicillin. We have conducted in silico work that shows that oxazolidinones are potentially active against T.p., are neuropenetrative and can be administered orally. As part of our current work, we are conducting the determination of drug susceptibility on infected rabbits to confirm the activity of the investigational drug and results will be published by the end of 2020. The objective of the current application is to assess whether a regimen of linezolid results in comparable serological and clinical outcomes than standard treatment in human patients with early syphilis and it has the potential to supersede the need of LP and IV antibiotic. We will conduct a randomized clinical trial (RCT) of 330 adult patients with infectious syphilis that will be randomly assigned to one of the two treatment arms. The primary outcome will be a four-fold decline in RPR titer or seroreversion at 12 months, and the absence of recurrent episodes caused by the same strain. We will use whole genome sequencing (WGS) to differentiate true treatment failures (a recurrent episode with the same strain) from re-infection.

34 IUSTI Congress - European Congres on Sexually transmitted Infections and HIV/AIDS
Bucharest, September 3-5,