NCT06907316

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Bulovka Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2021-07-13
• Primary completion: 2024-08-01
• Completion: 2024-08-01
• First posted: 2025-04-02
• Last updated: 2025-04-02

Locations

2 sites across 1 country: Czechia