Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2025-12-26 @ 11:09 AM
NCT ID:
NCT03752112
Eligibility Criteria:
Inclusion Criteria:
1. Female, 18 years of age or older
2. Non-pregnant
3. Able to provide informed consent
4. Test positive for syphilis with a positive TPPA AND an RPR titer equal to or greater than 1:8
5. Non-cephalosporin allergic
6. Non-penicillin allergic
7. Agree to be called once a day by study staff to be reminded to take study drug
8. Able to swallow pills
9. Willing to attend follow-up visits at 3, 6, and 9 months after completion of the study treatment
10. Willing to take oral contraceptive or use condom to prevent pregnancy during the study period
11. HIV negative
Exclusion Criteria:
1\) Female under 18 years of age 2) HIV positive 3) Pregnancy test positive or clinical pregnancy 4) Prior history of syphilis or syphilis treatment within 6 months of study screening 5) Allergy to penicillin or cephalosporins (including allergy to cefixime) 6) In the judgment of the interviewer, has a medical condition or other factor that might affect their ability to follow the protocol 7) Previous enrollment in the study 8) Presenting a condition that would not allow reliable informed consent (alcohol abuse or substance misuse) 9) Lacking mental capacity to give informed consent to participation
\-
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03752112
Study Brief:
Protocol Section:
NCT03752112