Cefixime Versus Benzathine Penicillin G in Treatment of Early Syphilis (NCT06907316) | Clinical Trial Compass
TerminatedPhase 4
Cefixime Versus Benzathine Penicillin G in Treatment of Early Syphilis
Stopped: For financial and personnel reasons, patient recruitment was carried out in only one of the planned centers.
Czechia61 participantsStarted 2021-07-13
Plain-language summary
This study evaluates the efficacy (non-inferiority) and safety of a new antibiotic treatment (cefixime), which has been previously used for single dose therapy of gonorrhoea in many years , in the treatment of early syphilis. Participants will be randomized to one of two study arms and will receive either expirimental regimen (cefixime) or the current standard antibiotic regimen (benzathine penicillin G). New treatment alternatives for syphilis could ensure that people are appropriately treated during periods or in settings of benzathine penicillin G stock out, penicillin allergy, or other intolerance to penicillin injection. This study may also identify an oral regimen for settings in which injections are not feasible.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 18 years of age or older
✓. Non-pregnant, non breastfeeding
✓. Able to provide informed consent
✓. Clinically or laboratory-confirmed primary, secondary or early latent syphilis with a positive rapid treponemal test and an RPR/VDRL titer equal to or greater than 1:8
✓. Non-cephalosporin allergic
✓. Non-penicillin allergic
✓. Agree to be occasionally called by study staff to be reminded to take study drug
✓. Willing to attend follow-up visits
Exclusion criteria
✕. Under 18 years of age
✕. Pregnancy, breastfeeding
✕. Prior history of syphilis in last two years
What they're measuring
1
Serological cure
Timeframe: from baseline (treatment) to 3 months after treatment