Cefixime Clinical Trial

Study Overview
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Brief Summary
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This study aims to evaluate the efficacy of cefixime compared to benzathine penicillin G in the treatment of syphilis.

Detailed Description
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This will be a randomized, multisite, open-label, non-inferiority clinical trial to evaluate the effectiveness of cefixime (400mg orally, twice a day, for 10 days) compared to benzathine penicillin G (2.4 million units, intramuscularly) in patients with and without HIV infection. In total, 400 participants with early syphilis will be enrolled from 9 clinical sites in the U.S. and Peru. Participants will participate in follow-ups to monitor clinical outcomes and serological response (RPR titer) every 3 months for 9 months. Study findings may identify an efficacious alternative syphilis treatment to penicillin, effective for people living with HIV infection, to help address the crisis of penicillin shortages and offer options for those with penicillin allergy.

Official Title
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Clinical Trial Comparing the Effectiveness of Cefixime Versus Penicillin G for Treatment of Early Syphilis

Conditions
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Syphilis, Human Immunodeficiency Virus

Intervention / Treatment
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* Drug: Cefixime 400mg
* Drug: benzathine penicillin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed cases of primary, secondary, or early latent syphilis with RPR titer ≥1:8 within 3 weeks prior to enrollment 18 years of age or older Able to provide informed consent Individuals with HIV infection must be on treatment for HIV infection and virologically suppressed (viral load <200 copies/mL) or have a CD4 count ≥ 350 cells/mm3 according to most recent labs before study enrollment Exclusion Criteria: Pregnancy or a positive pregnancy test on the day of enrollment Patients showing signs and symptoms of neurosyphilis Serofast RPR titer, defined as persistently positive RPR titer without more than 4-fold (2-titer level) change for 12 months or greater Recent (within the past 7 days) or concomitant antimicrobial therapy with activity against syphilis, namely azithromycin, doxycycline, ceftriaxone, or other beta-lactam antibiotics (e.g. amoxicillin) Individuals with HIV infection who report HIV treatment interruption for more than 4 weeks since their most recent viral load or CD4 test Self-reported allergy to cephalosporins or penicillin Unwilling or unable to attend follow-up visits

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cefixime<br>Oral cefixime 400mg, taken twice a day for 10 days | Drug: Cefixime 400mg<br>* Oral cefixime 400 mg, one capsule, twice a day for 10 days<br>* Other names: supprax;|
| Active Comparator: Benzathine Penicillin G<br>Single intramuscular injection of 2.4 million units of benzathine penicillin G | Drug: benzathine penicillin<br>* Standard of care benzathine penicillin G, one intramuscular injection, 2.4MU<br>* Other names: bicillin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response to treatment | Percentage of cefixime participants with a 4-fold decrease or greater in the serum RPR titer 3 or 6 months after treatment completion | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cefixime, Treponema pallidum, Penicillin, Early Syphilis