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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
61
cefixime 400 mg taken orally two times a day for 14 consecutive days
single dose of benzathine penicillin G 2.4 MIU intramuscularly
Národní referenční laboratoř pro syfilis, Státní zdravotní ústav
Prague, Czechia
Fakultní nemocnice Bulovka
Prague, Czechia
Serological cure
a 4-fold or more (≥2 dilution steps) decrease in rapid plasma reagin (RPR) or veneral disease reach laboratory test (VDRL) titer
Time frame: from baseline (treatment) to 3 months after treatment
Secondary serological cure
a 4-fold or more (≥2 dilution steps) decrease in rapid plasma reagin (RPR) or veneral disease reach laboratory test (VDRL) titer
Time frame: from baseline (treatment) to 6 and 12 months after treatment
Treatment safety
Occurrence of treatment-related severe adverse events in treatment groups
Time frame: from baseline till the end of follow-up (12 months from baseline)
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