Status:
UNKNOWN
Trial Evaluating the Clinical Efficacy of Cefixime for Treatment of Early Syphilis in Non-pregnant Women
Lead Sponsor:
World Health Organization
Conditions:
Syphilis Female
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Hypotheses The antibiotic, Cefixime, for use in non-pregnant women with early syphilis will be efficacious and safe. Primary Objective The primary objective of the study is to demonstrate the efficac...
Detailed Description
Hypotheses The antibiotic, Cefixime, for use in non-pregnant women with early syphilis will be efficacious and safe. Primary Objective The primary objective of the study is to demonstrate the efficac...
Eligibility Criteria
Inclusion
- Female, 18 years of age or older
- Non-pregnant
- Able to provide informed consent
- Test positive for syphilis with a positive TPPA AND an RPR titer equal to or greater than 1:8
- Non-cephalosporin allergic
- Non-penicillin allergic
- Agree to be called once a day by study staff to be reminded to take study drug
- Able to swallow pills
- Willing to attend follow-up visits at 3, 6, and 9 months after completion of the study treatment
- Willing to take oral contraceptive or use condom to prevent pregnancy during the study period
- HIV negative
Exclusion
- 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
- \-
Key Trial Info
Start Date :
November 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2021
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT03752112
Start Date
November 22 2019
End Date
September 30 2021
Last Update
February 5 2020
Active Locations (1)
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1
Fortaleza University
Fortaleza, Ceará, Brazil