Trep-AB
Research type
Research Study
Full title
Oral and Neuro-Penetrative Alternative Antibiotics for Patients with Syphilis
IRAS ID
1006816
Contact name
Gosala Gopalakrishnan
Contact email
Sponsor organisation
Lluita_Fight AIDS and Infectious Diseases Foundation
Eudract number
2020-005604-19
Clinicaltrials.gov Identifier
Research summary
Syphilis is a sexually transmitted infection (STI), which can cause serious health problems and become life threatening if left untreated. It is caused by the bacterium Treponema pallidum (T.p.) which crosses the blood-brain barrier invading the central nervous system in 40% of patients, usually without symptoms.
The infection has four stages (primary, secondary, latent and tertiary), with each stage having different signs and symptoms. Primary syphilis occurs approximately 2-6 weeks after contact with the appearance of sores/lesions on the skin. Without treatment, the infection progresses through the early stages. During the latent stage, there may be no visible symptoms, but the disease can lie dormant for years. Tertiary syphilis can affect various organ systems (including the heart and brain) up to decades after the first infection and lead to death.
Since 2000, the incidence of syphilis has increased globally, with an estimated 36 million prevalent cases, and an annual incidence of 6 million new cases which has serious implications for population health and health services. Syphilis can be treated with antibiotics but the current treatment Benzathine penicillin (BPG) does not cross the blood-brain barrier. It is usually given by a health professional as an intramuscular injection into the thigh. The TREP-AB trial aims to test how well the antibiotic, linezolid (LZD) works in comparison to BPG in patients with early syphilis. Linezolid is a licensed product with a long history of use. It was initially used as a reserved antibiotic in severe infections but now widely used, but not for this indication. In this trial, it will be given as a tablet twice a day for 10 days.
Potential participants meeting eligibility criteria will be randomly assigned to receive either LZD or BPG (control arm). They will be followed for up to 48 weeks with weekly/phone visits for the first 2-6 weeks. Blood and swabs (from lesions) will be taken throughout the study.REC name
London - Westminster Research Ethics Committee
REC reference
23/LO/0185
Date of REC Opinion
17 Oct 2023
REC opinion
Further Information Favourable Opinion