Syphilis, Early Syphilis
Conditions
Keywords
syphilis, cefixime, penicillin
Brief 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.
Detailed 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.
Interventions
DRUGCefixime 400 milligram Oral Capsule [Suprax]
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
Sponsors
AIDS Healthcare Foundation
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Response | 3 or 6 months after treatment completion | subjects who have a 4-fold decrease (from study entry Rapid plasma reagin) in Rapid plasma reagintiters from baseline at 3 or 6 months will be considered a positive treatment response. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Benzathine Penicillin G Patients of the Penicillin Group will receive the standard of care treatment. This is one intramuscular injection of 2.4 million units Benzathine Penicillin G. The group will consist of 50 patients.
Benzathine Penicillin G: 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 | 31 |
| Cefixime Group Patients of the Cefixime Group will receive Cefixime 400 mg, per os, one tablet, two times per day, for ten consecutive days. The study team will provide the medication.
The group will consist of 50 patients.
Cefixime 400 milligram Oral Capsule \[Suprax\]: The intervention group will receive Cefixime 400mg, one tablet twice per day, for ten consecutive days | 27 |
| Total | 58 |
Baseline characteristics
| Characteristic | Benzathine Penicillin G | Cefixime Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 31 Participants | 26 Participants | 57 Participants |
| Age, Continuous | 39 years | 39 years | 39 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 19 Participants | 18 Participants | 37 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 9 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race/ethnicity Hispanic/Latinx, or Spanish Origin | 19 Participants | 18 Participants | 37 Participants |
| Race/Ethnicity, Customized Race/ethnicity Non-Hispanic African American | 5 Participants | 4 Participants | 9 Participants |
| Race/Ethnicity, Customized Race/ethnicity Non-Hispanic Asian/Hawaiian/Pacific Islander | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Race/ethnicity Non-Hispanic White | 6 Participants | 4 Participants | 10 Participants |
| Region of Enrollment United States | 31 Participants | 27 Participants | 58 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 31 Participants | 27 Participants | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 27 |
| other Total, other adverse events | 0 / 31 | 0 / 27 |
| serious Total, serious adverse events | 0 / 31 | 1 / 27 |
Outcome results
Primary
Treatment Response
subjects who have a 4-fold decrease (from study entry Rapid plasma reagin) in Rapid plasma reagintiters from baseline at 3 or 6 months will be considered a positive treatment response.
Time frame: 3 or 6 months after treatment completion
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Benzathine Penicillin G | Treatment Response | 14 Participants |
| Cefixime Group | Treatment Response | 13 Participants |