IMPAACT 2044
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 during pregnancy. Up to 78 pregnant women receiving (1) ceftriaxone for indications other than syphilis or (2) benzathine penicillin G for treatment of syphilis from non-study clinical care providers will be enrolled at study sites located in the United States to achieve 60 evaluable pregnant participants. Approximately 22 infants of pregnant participants receiving benzathine penicillin G will also be enrolled.
The study includes two arms, with Arm 1 subdivided by route of administration:
- Arm 1A: Intravenous (IV) ceftriaxone
- Arm 1B: Intramuscular (IM) ceftriaxone
- Arm 2: IM benzathine penicillin G
Evaluability will be determined based on receipt of the drug under study as prescribed and completion of PK sampling. 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 was completed in January 2025. IMPAACT sites located in the US were invited to participate based on availability of the study population (pregnant women receiving ceftriaxone or benzathine penicillin G from non-study clinical care providers) and ability to meet the study's operational requirements.