Cefixime for Alternative Syphilis Treatment
Condition: Syphilis; Early Syphilis
MeSH terms: Syphilis
Intervention: Cefixime 400 milligram Oral Capsule [Suprax]; Benzathine Penicillin G
Intervention description: The intervention group will receive Cefixime 400mg, one tablet twice per day, for ten consecutive days; The control group will receive Benzathine Penicillin G 2.4 Million Units intramuscularly for treatment of syphilis. Penicillin is the indicated treatment for syphilis infection
Intervention MeSH terms: Penicillins; Cefixime; Penicillin G; Penicillin G Benzathine; Penicillin G Procaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 58.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: syphilis; cefixime; penicillin

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 18 years of age or older and able to provide informed consent

          2. Cases of primary, secondary or early latent syphilis with RPR titer ≥1:8 within 3
             weeks prior to enrollment.

          3. 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

          4. Non-cephalosporin allergic

          5. 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

          6. Able to swallow pills

        Exclusion Criteria:

          1. Pregnancy or positive pregnancy test

          2. Serofast RPR titer (prior titer 1:8 or greater)

          3. Recent (less than 7 days) or concomitant antimicrobial therapy with activity against
             syphilis.

          4. Cephalosporin allergy: previous episode of flushing, urticaria, angioedema, rhinitis,
             bronchospasm, and anaphylactic shock, rash after taking cephalosporin.

          5. Penicillin allergy: previous episode of flushing, urticaria, angioedema, rhinitis,
             bronchospasm, and anaphylactic shock, rash after receiving Penicillin.

          6. Has a medical condition or other factor that might affect their ability to follow the
             protocol