Cefixime Versus Benzathine Penicillin G in Treatment of Early Syphilis

Phase 4

Terminated

• Conditions: Syphilis
• Interventions: Drug: Cefixime 400mg; Drug: Benzathine penicillin 2.4 million units

• Registration Number: NCT06907316
• Lead Sponsor: Bulovka Hospital

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-13
• Primary Completion: 2024-08-01
• Study Completion: 2024-08-01
• Status Verified: 2025-03
• Study First Submitted: 2025-03-26
• Study First Submitted QC: 2025-03-26
• Last Update Submitted: 2025-03-26
• Study First Posted: 2025-04-02
• Last Update Posted: 2025-04-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

1. 18 years of age or older
2. Non-pregnant, non breastfeeding
3. Able to provide informed consent
4. 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
5. Non-cephalosporin allergic
6. Non-penicillin allergic
7. Agree to be occasionally called by study staff to be reminded to take study drug
8. Willing to attend follow-up visits

Exclusion Criteria

1. Under 18 years of age
2. Pregnancy, breastfeeding
3. Prior history of syphilis in last two years
4. Allergy or contraindication to penicillin or cephalosporins (including allergy to cefixime)
5. Systemic antibiotic therapy in last two weeks
6. Previous enrollment in the study
7. Presenting a situation or condition that would not allow reliable study follow up (For example: frequent travel, alcohol abuse or substance misuse)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cefixime	Cefixime 400mg	cefixime 400 mg taken orally two times a day for 14 consecutive days
benzathine penicillin G	Benzathine penicillin 2.4 million units	benzathine penicillin G 2.4 MIU single dose intramuscularly

Primary Outcome Measures

Name	Time	Method
Serological cure	from baseline (treatment) to 3 months after treatment	a 4-fold or more (≥2 dilution steps) decrease in rapid plasma reagin (RPR) or veneral disease reach laboratory test (VDRL) titer

Secondary Outcome Measures

Name	Time	Method
Secondary serological cure	from baseline (treatment) to 6 and 12 months after treatment	a 4-fold or more (≥2 dilution steps) decrease in rapid plasma reagin (RPR) or veneral disease reach laboratory test (VDRL) titer
Treatment safety	from baseline till the end of follow-up (12 months from baseline)	Occurrence of treatment-related severe adverse events in treatment groups

Trial Locations

Locations (2)

Fakultní nemocnice Bulovka; 🇨🇿 Prague, Czech Republic

Národní referenční laboratoř pro syfilis, Státní zdravotní ústav; 🇨🇿 Praha, Czech Republic