Clinical Trials Logo

Clinical Trial Summary

The goal of the study is to evaluate the efficacy of oral cefixime as an alternative treatment for syphilis infection. One hundred adult patients (≥18 years old) with syphilis infection (positive Treponema Pallidum Particle Agglutination assay and RPR titer ≥ 1/8) will be recruited. Participants will be randomized (1:1) to receive either the standard of care Penicillin or Cefixime. During the study, participants will visit the clinic up to 5 times; at baseline visit, at 3, 6, 12 months after treatment initiation. Participants of the cefixime group will be required to visit the clinic 14 days after treatment initiation. In each visit, participants will be asked about current symptoms and do laboratory tests for syphilis (RPR). Subjects who have a 4-fold decrease (from study entry RPR) in RPR titers from baseline at 6 months will be considered a positive treatment response.


Clinical Trial Description

Syphilis is a major issue worldwide causing 5.6 million new cases of syphilis worldwide, of which over 900,000 are pregnant women. It is also responsible for congenital infections causing fetal loss or stillbirth or, in a live-born infant, neonatal death, prematurity and low birth weight. Penicillin is the currently used treatment. However, lack of penicillin and alternatives to treatment often hinder treatment and prevention efforts. Cefixime is an FDA-approved, orally administered third-generation cephalosporin that is currently used for the treatment of a wide range of infections, including urinary tract infections. Our goal is to evaluate the efficacy and safety of oral cefixime as an alternative treatment for syphilis infection. One hundred adult patients (≥18 years old) with syphilis infection will be recruited. Eligible participants will have laboratory-confirmed syphilis infection with a positive Treponema pallidum Particle Agglutination (TPPA) assay and RPR (Rapid Plasma Reagin ) titer ≥ 1/8. Participants will be randomized (1:1) to receive either the standard of care Penicillin or Cefixime. During the study, participants will visit the clinic 5 times; at baseline visit, demographic, clinical information and laboratory test results for syphilis will be recorded and treatment will start. Depending on the study group, the treatment plan will be oral Cefixime 400mg, twice per day for ten consecutive days or one dose of intramuscular Penicillin. Patients will be required to visit the clinic two weeks after treatment initiation to verify adverse effects. Follow up visits will occur at 3, 6 and 12 months after treatment initiation. In each visit, participants will be asked about current symptoms, interval sexual history, concomitant antibiotic use and possible adverse reactions. Subjects will also have a venipuncture blood specimen collected for syphilis testing (RPR). Subjects who have a 4-fold decrease (from study entry RPR) in RPR titers from baseline at 6 months will be considered a positive treatment response. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03660488
Study type Interventional
Source University of California, Los Angeles
Contact
Status Completed
Phase Phase 2
Start date September 3, 2018
Completion date January 30, 2021

See also
  Status Clinical Trial Phase
Recruiting NCT05548426 - Linezolid for Syphilis Pilot Study Phase 2
Completed NCT02191527 - Evaluating the Effectiveness of Point-of-care Diagnostic Technologies in MCH Services in Mozambique N/A
Completed NCT01439503 - Safer Sex Program for Young African-American Men Phase 2
Completed NCT02257658 - Efficacy of Doxycycline Prophylaxis to Reduce Syphilis in High-Risk, HIV-Positive MSM N/A
Terminated NCT01540227 - Penicillin Therapeutic Drug Monitoring in the Treatment of Infectious Syphilis.
Completed NCT02611765 - Syphilis Response to Higher Penicillin Dosage: The 2.4 Versus 7.2 Study Phase 4
Not yet recruiting NCT06428643 - A Seek, Test, and Treat Intervention to Reduce Chlamydia Trachomatis Disparities N/A
Completed NCT03709862 - Global Syphilis Sequencing
Completed NCT03637660 - Phase 4 Comparative Trial of Benzathine Penicillin G for Treatment of Early Syphilis in Subjects With or Without HIV Infection Phase 4
Active, not recruiting NCT03310424 - Transcriptomic and Next Generation Sequencing Approaches to Infection With Treponema Pallidum
Completed NCT00207506 - Lay Health Advisors for Sexually Transmitted Disease Prevention Phase 1/Phase 2
Completed NCT00213018 - Safety, Acceptability and Preliminary Effectiveness of Carraguard™ (PC-515) in Preventing HIV/STI Transmission Phase 2
Recruiting NCT06059443 - mLab App Plus: A Randomized Controlled Trial of a Mobile Health (mHealth) Intervention N/A
Completed NCT04480749 - Syphilis Self-testing to Expand Test Uptake Among Men Who Have Sex With Men (SST) Phase 4
Not yet recruiting NCT06058286 - MENJAGA: Continuous Quality Improvement for Antenatal HIV, Syphilis and Hepatitis B Testing in Indonesia N/A
Active, not recruiting NCT03980223 - Evaluation of Doxycycline Post-exposure Prophylaxis to Reduce Sexually Transmitted Infections in PrEP Users and HIV-infected Men Who Have Sex With Men Phase 4
Completed NCT01465607 - Implementation of an Efficacious Intervention for High Risk Women in Mexico N/A
Completed NCT00553111 - Video Tool to Promote Knowledge of Syphilis as Facilitator of HIV Transmission N/A
Active, not recruiting NCT06367621 - Retrospective Study of iStatis Syphilis Ab Test (POC)
Completed NCT02454816 - Introduction Study of Dual HIV & Syphilis Rapid Diagnostic Tests in Antenatal Clinics in Colombia N/A