Clinical Trial

Study of Ceftriaxone and Benzathine Penicillin G During Pregnancy

Recruiting
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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.
Protocol Amendment History 2 changes
notable Primary completion pushed: 2026-08-29 -> 2027-01-15 2026-08-07
minor Completion pushed: 2027-05-17 -> 2027-09-30 2026-08-07
Trial Details
NCT Number NCT07207876
Lead Sponsor International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Mental Health (NIMH)
Conditions Pregnancy
Enrollment 110 participants
Start Date 2026-02-16
Primary Completion 2027-01-15 (estimated)
Study Completion 2027-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-06