Cefixime Clinical Trial
Study Details
Study Description
Brief Summary
This study aims to evaluate the efficacy of cefixime compared to benzathine penicillin G in the treatment of syphilis.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Detailed 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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Cefixime Oral cefixime 400mg, taken twice a day for 10 days |
Drug: Cefixime 400mg
Oral cefixime 400 mg, one capsule, twice a day for 10 days
|
Active Comparator: Benzathine Penicillin G Single intramuscular injection of 2.4 million units of benzathine penicillin G |
Drug: benzathine penicillin
Standard of care benzathine penicillin G, one intramuscular injection, 2.4MU
|
Outcome Measures
Primary Outcome Measures
- Response to treatment [6 months]
Percentage of cefixime participants with a 4-fold decrease or greater in the serum RPR titer 3 or 6 months after treatment completion
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Diagnosed cases of primary, secondary, or early latent syphilis with RPR titer ≥1:8 within 3 weeks prior to enrollment
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18 years of age or older
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Able to provide informed consent
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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:
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Pregnancy or a positive pregnancy test on the day of enrollment
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Patients showing signs and symptoms of neurosyphilis
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Serofast RPR titer, defined as persistently positive RPR titer without more than 4-fold (2-titer level) change for 12 months or greater
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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)
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Individuals with HIV infection who report HIV treatment interruption for more than 4 weeks since their most recent viral load or CD4 test
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Self-reported allergy to cephalosporins or penicillin
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Unwilling or unable to attend follow-up visits
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University of Southern California | Los Angeles | California | United States | 90032 |
Sponsors and Collaborators
- University of Southern California
- AIDS Healthcare Foundation
- Universidad Peruana Cayetano Heredia
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HS-21-00288