Cefixime Versus Benzathine Penicillin G in Treatment of Early Syphilis

Cefixime Versus Benzathine Penicillin G in Treatment of Early Syphilis - a Randomized, Multicentre, Non-inferiority, Open Label Trial

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06907316

Enrollment

Registered

2025-04-02

Start date

2021-07-13

Completion date

2024-08-01

Last updated

2025-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Syphilis

Keywords

syphilis, treatment, cefixime

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.

Interventions

DRUGCefixime 400mg

cefixime 400 mg taken orally two times a day for 14 consecutive days

DRUGBenzathine penicillin 2.4 million units

single dose of benzathine penicillin G 2.4 MIU intramuscularly

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026