Cefixime for Alternative Syphilis Treatment

Completed · Phase 2

Conditions studied: Syphilis, Early Syphilis

In brief

The goal of the study is to evaluate the efficacy of oral cefixime as an alternative treatment for syphilis infection. One hundred adult patients (≥18 years old) with syphilis infection (positive Treponema Pallidum Particle Agglutination assay and RPR titer ≥ 1/8) will be recruited. Participants will be randomized (1:1) to receive either the standard of care Penicillin or Cefixime. During the study, participants will visit the clinic up to 5 times; at baseline visit, at 3, 6, 12 months after treatment initiation. Participants of the cefixime group will be required to visit the clinic 14 days after treatment initiation. In each visit, participants will be asked about current symptoms and do laboratory tests for syphilis (RPR). Subjects who have a 4-fold decrease (from study entry RPR) in RPR titers from baseline at 6 months will be considered a positive treatment response.

Key facts

Study ID

NCT03660488

Run by

University of California, Los Angeles

People needed

58

Starts

2018-09-03

Expected to finish

2021-01-30

Last updated by the study team

2022-07-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 years of age or older and able to provide informed consent
• Cases of primary, secondary or early latent syphilis with RPR titer ≥1:8 within 3 weeks prior to enrollment.
• HIV infected individuals willing to participate in the study must have CD4 count ≥350 cells/μl within the last 4 weeks and be virally suppressed (i.e., viral load ≤ 200 copies/mL) for HIV for the 6 months prior to enrolment with the most recent results within the last 4 weeks. inclusion
• Non-cephalosporin allergic
• Able to travel to the clinic once a day or be available for phone calls or receive text messages for at least 7-10 days and willing to attend follow-up visits
• Able to swallow pills

You may not qualify if…

• Pregnancy or positive pregnancy test
• Serofast RPR titer (prior titer 1:8 or greater)
• Recent (less than 7 days) or concomitant antimicrobial therapy with activity against syphilis.
• Cephalosporin allergy: previous episode of flushing, urticaria, angioedema, rhinitis, bronchospasm, and anaphylactic shock, rash after taking cephalosporin.
• Penicillin allergy: previous episode of flushing, urticaria, angioedema, rhinitis, bronchospasm, and anaphylactic shock, rash after receiving Penicillin.
• Has a medical condition or other factor that might affect their ability to follow the protocol

Where it is running

• AHF Westside — Beverly Hills, California, United States
• AHF Downtown Healthcare Center — Los Angeles, California, United States
• AHF Carl Bean — Los Angeles, California, United States
• AHF Hollywood Healthcare Center — Los Angeles, California, United States
• AHF Wellness on Western Center — Los Angeles, California, United States
• AHF Oakland Wellness Center — Oakland, California, United States
• AHF Healthcare Center Oakland — Oakland, California, United States
• AHF San Francisco — San Francisco, California, United States
• AHF Valley — Sherman Oaks, California, United States
• AHF Las Vegas Healthcare Center — Las Vegas, Nevada, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.