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Determining the timing of Chlamydia trachomatis test of cure

Determining the timing of Chlamydia trachomatis test of cure. Sarah K Tillman, MD Gweneth Lazenby , MD MSCR MUSC Obstetrics and Gynecology. Chlamydia Trachomatis. 3 rd most common STI in US Risk factors Impact of estrogen & progesterone. Center for Disease Control and Prevention, 2014

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Determining the timing of Chlamydia trachomatis test of cure

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  1. Determining the timing of Chlamydia trachomatis test of cure Sarah K Tillman, MD GwenethLazenby, MD MSCR MUSC Obstetrics and Gynecology

  2. Chlamydia Trachomatis • 3rd most common STI in US • Risk factors • Impact of estrogen & progesterone Center for Disease Control and Prevention, 2014 Hall et all. 2011. Cell Microbiology Kauschi et al. 2000. Immunology

  3. Complications and Screening Center for Disease Control and Prevention, 2014

  4. Previous Research • 79% negative at Day 14 • 3-4 day intervals until 14 days following treatment • Multiple linear regression analysis • 100% = 17 days • Presence of Chlamydia DNA or rRNA up to 51 days Renault et al. 2011. Sex Health Dukers-Muijrers et al. 2012. PLOSone

  5. Objective • Determine the time to negative Chlamydia NAAT following therapy in pregnant and non-pregnant women • Determine if pregnancy affects the time to clearance of infection • Recommend test of cure timing in pregnant and non-pregnant women

  6. Sample Size Calculation Survival Analysis Assumptions • Pregnant women will take 7 days longer to clear Chlamydia infection • Accrual time: 21 days • Power 80% • Alpha 0.05 Sample size: 33 pregnant and 33 non-pregnant subjects

  7. Methods • Weekly Visits • Chlamydia NAAT • Survey • Condoms Enrollment + test Eligibility Screening • First Visit • Consent • BV gram stain • Trich NAAT • Survey • Condoms • Compensation • Chlamydia Tx • Participation Complete • Negative test • Patient notified

  8. Data Analysis • Survival analysis • Event = negative TOC • Use Log Rank test to compare the time to negative TOC in pregnant and non-pregnant women with Chlamydia • Continuous variables -> t-test • Age of sexual debut -> Wilcoxon rank-sum test • Categorical variables -> Fisher's exact test

  9. Results (Interim analysis) April 13, 2014 • N = 37, study completion = 30 • Mean age 24 • 60% pregnant (22) • Median age of sexual debut 16 • Median number of lifetime partners 5 • 68% report a history of an STI • 14% are diagnosed with another STI at time of CT • 35% are diagnosed with BV at initial visit

  10. Results

  11. Results Log-rank test p value = 0.2

  12. Conclusions • Recruitment ongoing… • 38 enrolled thus far (66 needed) • Average 4/month • 23% loss to follow-up rate • Expected study completion: April 2015 • Study advertising • Informative handout at screening

  13. Acknowledgements • Dr. Lazenby • Dr. Pierce • Tamara Pfeffer, research coordinator

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