Study on the use of Cefixime for the treatment of syphilis in Brazil

INTERVENTION: Drug Drug Therapy This is a phase 1/2 clinical trial to assess the efficacy and safety of Cefixima for use in the treatment of women with early syphilis. This is a randomized, non‐comparative and open study that assesses the efficacy and safety of Cefixima 400mg ingested twice a day for 10 consecutive days in non‐pregnant women with early syphilis. To evaluate the performance of benzathine penicillin in the study population that is being used for Cefixima, we will include a contemporary group of participants who receive standard treatment of benzathine penicillin treatment according to the Brazilian guidelines for the treatment of sexually transmitted infections (STI). We will use a proportion of 2 patients receiving the antibiotic Cefixime for 1 patient receiving penicillin. In total 120 women will be part of the intervention group and will receive Cefixima 400 mg twice daily for 10 days. Sixty women will be part of the contemporaneous group and receive 2.4 million of benzathine penicillin units (1.2 million units in each gluteus) once, according to national guidelines. CONDITION: A00‐B99 Syphilis Syphilis ; Syphilis PRIMARY OUTCOME: It is expected to detect a decrease of 4 titles in the RPR exam at 6 months after treatment when compared to the initial values. Women who present this decrease in title will be considered as having a positive response to treatment. SECONDARY OUTCOME: is expected to evaluate the safety and tolerability of Cefixima in the treatment of syphilis through the proportion of treated patients who present mild, moderate, severe or life‐threatening adverse events, temporally or not associated with the medicine of Study. The common terminology criteria for adverse events (CTCAE) will be used to evaluate the side effects and their severity. INCLUSION CRITERIA: 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