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Cefixime Versus Benzathine Penicillin G in Treatment of Early Syphilis

NCT06907316 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2025-04-02

No results posted yet for this study

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.

Conditions

  • Syphilis

Interventions

DRUG

Cefixime 400mg

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

DRUG

Benzathine penicillin 2.4 million units

single dose of benzathine penicillin G 2.4 MIU intramuscularly

Sponsors & Collaborators

  • Všeobecná fakultní nemocnice Praha

    collaborator UNKNOWN

  • Národní referenční laboratoř pro syfilis, Státní zdravotní ústav

    collaborator UNKNOWN

  • Örebro University, Sweden

    collaborator OTHER

  • Bulovka Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-13
Primary Completion
2024-08-01
Completion
2024-08-01

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06907316 on ClinicalTrials.gov