Status:
TERMINATED
Cefixime Versus Benzathine Penicillin G in Treatment of Early Syphilis
Lead Sponsor:
Bulovka Hospital
Collaborating Sponsors:
Všeobecná fakultní nemocnice Praha
Národní referenční laboratoř pro syfilis, Státní zdravotní ústav
Conditions:
Syphilis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 tre...
Eligibility Criteria
Inclusion
- 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
- Under 18 years of age
- Pregnancy, breastfeeding
- Prior history of syphilis in last two years
- Allergy or contraindication to penicillin or cephalosporins (including allergy to cefixime)
- Systemic antibiotic therapy in last two weeks
- Previous enrollment in the study
- Presenting a situation or condition that would not allow reliable study follow up (For example: frequent travel, alcohol abuse or substance misuse)
Key Trial Info
Start Date :
July 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2024
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT06907316
Start Date
July 13 2021
End Date
August 1 2024
Last Update
April 2 2025
Active Locations (2)
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1
Národní referenční laboratoř pro syfilis, Státní zdravotní ústav
Prague, Czechia, 10000
2
Fakultní nemocnice Bulovka
Prague, Czechia, 18081