Cefixime Clinical Trial

Launched by UNIVERSITY OF SOUTHERN CALIFORNIA · Jun 29, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a medication called cefixime to see how well it works compared to benzathine penicillin G in treating syphilis, which is a sexually transmitted infection. The trial aims to provide more options for people diagnosed with primary, secondary, or early latent syphilis, especially for those living with HIV. To participate, you need to be at least 18 years old, have a recent diagnosis of syphilis with specific test results, and if you have HIV, your treatment must be effective, meaning your viral load is low.

If you join the study, you will receive either cefixime or benzathine penicillin G and will need to attend follow-up visits to monitor your health. It’s important to know that you cannot be pregnant, show signs of a certain type of syphilis called neurosyphilis, or have had certain recent treatments against syphilis. This trial is currently seeking participants, and your involvement could help improve treatments for syphilis, especially for those also managing HIV.

Gender

ALL

Eligibility criteria

• 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