Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03660488 |
| Other study ID # |
18-000665 |
| Secondary ID |
20181796 |
| Status |
Completed |
| Phase |
Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
September 3, 2018 |
| Est. completion date |
January 30, 2021 |
Study information
| Verified date |
July 2022 |
| Source |
University of California, Los Angeles |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
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.
