IMPAACT 2044
Study Status
DAIDS Number
Primary Protocol Team Members
Summary
IMPAACT 2044 is a Phase IV, multi-site, open-label, non-randomized, opportunistic study to characterize the pharmacokinetics (PK) and safety of ceftriaxone and benzathine penicillin G, conducted among approximately 58 pregnant people at least 18 years old, as well as infants of pregnant people with syphilis. Pregnant participants receiving ceftriaxone and/or benzathine penicillin G per clinical care (i.e., outside of the study) will be enrolled at study sites located in the United States. The study includes three arms:
- Arm 1A: Intravenous (IV) ceftriaxone
- Arm 1B: Intramuscular (IM) ceftriaxone
- Arm 2: IM benzathine penicillin G
Pregnant participants will remain on study until delivery or other pregnancy outcome, up to approximately 36 weeks total. Infant-participants will remain on study for up to 30 days post-birth to describe the frequency of congenital syphilis.
Site Selection Update
Site selection was initiated in October 2024 and closed in November 2024. IMPAACT sites located in the US were invited to participate based on availability of the target population (pregnant people receiving ceftriaxone and/or benzathine penicillin G as part of clinical care) and ability to meet the study’s operational requirements.