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:
Participant gender:
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
Details
Lead Sponsor:
World Health Organization
Treatments:
Cefixime Penicillin G Penicillin G Benzathine Penicillin G Procaine Penicillins