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IMPAACT 2044

Pharmacokinetics of Benzathine Penicillin and Ceftriaxone for Treatment of Syphilis During Pregnancy

Summary

IMPAACT 2044 is a Phase IV, multi-site, open-label, non-randomized, opportunistic pharmacokinetic (PK) study of ceftriaxone (CTX) and benzathine penicillin G (BPG) in pregnancy for treatment of syphilis. Participants with syphilis and receiving CTX or BPG as standard of care treatment (i.e., outside of the study) will be enrolled at study sites located in the United States. The study is designed to characterize the PK of CTX and BPG, as well as the kinetics of quantitative non-treponemal titer changes of BPG in each trimester of pregnancy. Participants will be actively followed for up to 14 days and will remain on study until delivery or other pregnancy outcome.

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