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Cefixime Versus Benzathine Penicillin G for Early Syphilis Treatment

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What is being tested

Cefixime 400mg

+ Benzathine penicillin 2.4 million units

Drug
Who is being recruted

Urogenital Diseases+9

+ Genital Diseases

+ Bacterial Infections and Mycoses

Over 18 Years
+15 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: July 2021
See protocol details

Summary

Principal SponsorBulovka Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 13, 2021

Actual date on which the first participant was enrolled.

This clinical trial is investigating whether a new antibiotic treatment, cefixime, is as effective and safe as the current standard treatment, benzathine penicillin G, for early syphilis. Syphilis is a sexually transmitted infection that needs timely and effective treatment to prevent complications. The study is important because it could provide a new treatment option for people who cannot receive penicillin, either due to allergies or because the injection is not available. It could also offer an oral alternative, making treatment easier in situations where injections are not practical. Participants in the study will be randomly assigned to receive either cefixime or benzathine penicillin G. Cefixime is taken orally, while benzathine penicillin G is given as an injection. The study will compare the effectiveness of these treatments in curing early syphilis and will monitor safety measures to ensure that the new treatment does not cause significant side effects. The goal is to see if cefixime can perform as well as the current standard treatment, potentially providing more flexibility in managing syphilis treatment. The study does not list specific primary outcomes, but it will focus on evaluating the efficacy and safety of the treatments.

Official TitleCefixime Versus Benzathine Penicillin G in Treatment of Early Syphilis - a Randomized, Multicentre, Non-inferiority, Open Label Trial
NCT06907316
Principal SponsorBulovka Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

61 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesBacterial Infections and MycosesBacterial InfectionsCommunicable DiseasesInfectionsSexually Transmitted DiseasesSpirochaetales InfectionsSyphilisTreponemal InfectionsSexually Transmitted Diseases, BacterialGram-Negative Bacterial Infections

Criteria

8 inclusion criteria required to participate
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

Show More Criteria

7 exclusion criteria prevent from participating
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)

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

Active Comparator
benzathine penicillin G 2.4 MIU single dose intramuscularly

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Suspended

Národní referenční laboratoř pro syfilis, Státní zdravotní ústav

Prague, CzechiaOpen Národní referenční laboratoř pro syfilis, Státní zdravotní ústav in Google Maps
Suspended

Fakultní nemocnice Bulovka

Prague, Czechia
Suspended2 Study Centers