Summary

for people ages 18 years and up (full criteria)
at UCLA
study started
estimated completion
Jeffrey D Klausner, MD MPH(ucla)

Description

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.

Official Title

Clinical Trial Evaluating the Clinical Efficacy of Cefixime for Treatment of Early Syphilis

Details

Syphilis is a major issue worldwide causing 5.6 million new cases of syphilis worldwide, of which over 900,000 are pregnant women. It is also responsible for congenital infections causing fetal loss or stillbirth or, in a live-born infant, neonatal death, prematurity and low birth weight. Penicillin is the currently used treatment. However, lack of penicillin and alternatives to treatment often hinder treatment and prevention efforts.

Cefixime is an FDA-approved, orally administered third-generation cephalosporin that is currently used for the treatment of a wide range of infections, including urinary tract infections. Our goal is to evaluate the efficacy and safety of oral cefixime as an alternative treatment for syphilis infection.

One hundred adult patients (≥18 years old) with syphilis infection will be recruited. Eligible participants will have laboratory-confirmed syphilis infection with a positive Treponema pallidum Particle Agglutination (TPPA) assay and RPR (Rapid Plasma Reagin ) titer ≥ 1/8. Participants will be randomized (1:1) to receive either the standard of care Penicillin or Cefixime.

During the study, participants will visit the clinic 5 times; at baseline visit, demographic, clinical information and laboratory test results for syphilis will be recorded and treatment will start. Depending on the study group, the treatment plan will be oral Cefixime 400mg, twice per day for ten consecutive days or one dose of intramuscular Penicillin. Patients will be required to visit the clinic two weeks after treatment initiation to verify adverse effects. Follow up visits will occur at 3, 6 and 12 months after treatment initiation. In each visit, participants will be asked about current symptoms, interval sexual history, concomitant antibiotic use and possible adverse reactions. Subjects will also have a venipuncture blood specimen collected for syphilis testing (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.

Keywords

Syphilis Early Syphilis cefixime penicillin Penicillins Penicillin G Penicillin G Benzathine Penicillin G Procaine Cefixime 400 milligram Oral Capsule [Suprax] Benzathine Penicillin G

Eligibility

You can join if…

Open to people ages 18 years and up

  1. 18 years of age or older and able to provide informed consent
  2. Test positive for syphilis: positive TPPA AND an RPR≥1:8
  3. HIV infected individuals willing to participate in the study must have CD4 count≥350 cells/mm3 and were virologically suppressed during the past 12 months (undetectable HIV viral load)
  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

You CAN'T join if...

  1. Pregnancy or positive pregnancy test
  2. Prior RPR 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

Locations

  • AHF San Francisco accepting new patients
    San Francisco California 94114 United States
  • AHF Westside accepting new patients
    Beverly Hills California 90211 United States
  • AHF Valley accepting new patients
    Sherman Oaks California 91403 United States
  • AHF Carl Bean accepting new patients
    Los Angeles California 90018 United States
  • AHF Hollywood Healthcare Center accepting new patients
    Los Angeles California 90027 United States
  • AHF Wellness on Western Center accepting new patients
    Los Angeles California 90027 United States
  • AHF Downtown Healthcare Center accepting new patients
    Los Angeles California 90015 United States
  • AHF Oakland Wellness Center accepting new patients
    Oakland California 94606 United States
  • AHF Healthcare Center Oakland accepting new patients
    Oakland California 94609 United States

Lead Scientist

  • Jeffrey D Klausner, MD MPH (ucla)
    Health Sciences Clinical Professor, Infectious Diseases. Authored (or co-authored) 453 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Los Angeles
ID
NCT03660488
Phase
Phase 2
Study Type
Interventional
Last Updated