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IMPAACT 2044

Phase IV Study of the Pharmacokinetics and Safety of Ceftriaxone and Benzathine Penicillin G During Pregnancy

Study Status

In Development

DAIDS Number

39132

Summary

IMPAACT 2044 is a Phase IV, multi-site, open-label, non-randomized, opportunistic study to characterize the pharmacokinetics (PK) and safety of ceftriaxone (CRO) and benzathine penicillin G (BPG), conducted among pregnant people at least 18 years old and their infants. Pregnant participants receiving CRO or BPG per clinical care (i.e., outside of the study) will be enrolled at study sites located in the United States. Pregnant participants will remain on study until delivery or other pregnancy outcome, up to approximately 36 weeks total. Infants will be followed for up to 30 days post-birth to describe the frequency of congenital syphilis.

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