Cefixime Versus Benzathine Penicillin G in Treatment of Early Syphilis

NCT06907316 | Terminated Phase 4

• 1 other identifier: 1.6.2021/10071/EK-Z
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 2

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.

Conditions

Syphilis

Keywords

syphilis; treatment; cefixime

Outcome Measures

Primary Outcomes (1)

• Serological cure

  a 4-fold or more (≥2 dilution steps) decrease in rapid plasma reagin (RPR) or veneral disease reach laboratory test (VDRL) titer

  from baseline (treatment) to 3 months after treatment

Secondary Outcomes (2)

• Secondary serological cure

  from baseline (treatment) to 6 and 12 months after treatment

• Treatment safety

  from baseline till the end of follow-up (12 months from baseline)

Study Arms (2)

Cefixime

EXPERIMENTAL

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

Drug: Cefixime 400mg

benzathine penicillin G

ACTIVE COMPARATOR

benzathine penicillin G 2.4 MIU single dose intramuscularly

Drug: Benzathine penicillin 2.4 million units

Interventions

Cefixime 400mg DRUG

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

Cefixime

Benzathine penicillin 2.4 million units DRUG

single dose of benzathine penicillin G 2.4 MIU intramuscularly

benzathine penicillin G

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Non-cephalosporin allergic
• Non-penicillin allergic
• Agree to be occasionally called by study staff to be reminded to take study drug
• Willing to attend follow-up visits

You may not qualify if:

• 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)
• Systemic antibiotic therapy in last two weeks
• Previous enrollment in the study
• Presenting a situation or condition that would not allow reliable study follow up (For example: frequent travel, alcohol abuse or substance misuse)

Sponsors & Collaborators

• Bulovka Hospital: lead
• Všeobecná fakultní nemocnice Praha: collaborator
• Národní referenční laboratoř pro syfilis, Státní zdravotní ústav: collaborator
• Örebro University, Sweden: collaborator

Study Sites (2)

Národní referenční laboratoř pro syfilis, Státní zdravotní ústav

Prague, 10000, Czechia

Location

Fakultní nemocnice Bulovka

Prague, 18081, Czechia

Location

MeSH Terms

Conditions

Syphilis

Interventions

Cefixime

Condition Hierarchy (Ancestors)

Treponemal Infections; Spirochaetales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cefotaxime; Cephacetrile; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair of Department

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 2, 2025
• Study Start: July 13, 2021
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (2)