NCT07207876

Study of Ceftriaxone and Benzathine Penicillin G During Pregnancy

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 110 (estimated)
• Sponsor: International Maternal Pediatric Adolescent AIDS Clinical Trials Group · Network
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

IMPAACT 2044 is a 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. Approximately 22 infants of pregnant participants receiving benzathine penicillin G will also be enrolled.

Detailed description

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. 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

Conditions

• Pregnancy

Interventions

Type	Name	Description
DRUG	Ceftriaxon	Ceftriaxone will not be provided as part of the study. Pregnant participants will receive these drugs as prescribed outside the study by their non-study clinical care provider
DRUG	Benzathine penicillin G	Benzathine penicillin G will not be provided as part of the study. Pregnant participants will receive these drugs as prescribed outside the study by their non-study clinical care provider

Timeline

• Start date: 2026-02-16
• Primary completion: 2026-08-29
• Completion: 2027-05-17
• First posted: 2025-10-06
• Last updated: 2026-03-27

Locations

9 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study