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

Phase 1

• Conditions: Syphilis; C01.252.400.840.744

• Registration Number: RBR-8sv2kp
• Lead Sponsor: niversidade de Fortaleza

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-26
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 210

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

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.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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.