Syphilis
Conditions
Interventions
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 assess
Drug
E02.319
Sponsors
Universidade de Fortaleza
Universidade de Fortaleza
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: Female under 18 years of age; HIV positive; pregnancy test positive or clinical pregnancy; prior history of syphilis or syphilis treatment within 6 months of study screening; allergy to penicillin or cephalosporins (including allergy to cefixime); in the judgment of the interviewer, has a medical condition or other factor that might affect their ability to follow the protocol; previous enrollment in the study; presenting a condition that would not allow reliable informed consent (alcohol abuse or substance misuse); lacking mental capacity to give informed consent to participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Brazil
Contacts
Public ContactMaria Alix Araujo
Universidade de Fortaleza
Outcome results
None listed