Trial Evaluating the Clinical Efficacy of Cefixime for Treatment of Early Syphilis in Non-pregnant Women

• Status: Recruiting
• Trial end date: 2021-09-30
• Target enrollment: 0
• Participant gender: Female

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 efficacy, as measured by a 4 fold decrease in Rapid Plasma Reagin (RPR) titer from baseline to 6 months after treatment, with Cefixime 400mg taken orally two times a day for 10 consecutive days.

Secondary Objective The secondary objective of the study is to determine the safety, as measured by the number of grade 3 or greater toxicities experienced, using the NIH/NCI toxicity score, during or after treatment with Cefixime 400mg taken orally two times a day for 10 consecutive days.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: World Health Organization
• Treatments: Cefixime; Penicillin G; Penicillin G Benzathine; Penicillin G Procaine; Penicillins

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

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