Cefixime Clinical Trial

University of Southern California

Status and phase: Enrolling; Phase 3

Conditions: Human Immunodeficiency Virus; Syphilis

Treatments: Drug: benzathine penicillin; Drug: Cefixime 400mg

Study type: Interventional

Funder types: Other

Identifiers

NCT04958122

HS-21-00288

Details and patient eligibility

About

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

Full description

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

400 participants in 2 patient groups

Cefixime

Experimental group

Description:

Oral cefixime 400mg, taken twice a day for 10 days

Treatment:

Drug: Cefixime 400mg

Benzathine Penicillin G

Active Comparator group

Description:

Single intramuscular injection of 2.4 million units of benzathine penicillin G

Treatment:

Drug: benzathine penicillin