Cefixime Versus Benzathine Penicillin G in Treatment of Early Syphilis

Bulovka Hospital

Status and phase: Terminated; Phase 4

Conditions: Syphilis

Treatments: Drug: Cefixime 400mg; Drug: Benzathine penicillin 2.4 million units

Study type: Interventional

Funder types: Other

Identifiers

NCT06907316

1.6.2021/10071/EK-Z

Details and patient eligibility

About

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.

Enrollment: 61 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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61 participants in 2 patient groups

Cefixime

Experimental group

Description:

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

Treatment:

Drug: Cefixime 400mg

benzathine penicillin G

Active Comparator group

Description:

benzathine penicillin G 2.4 MIU single dose intramuscularly

Treatment:

Drug: Benzathine penicillin 2.4 million units