Study of Ceftriaxone and Benzathine Penicillin G During Pregnancy
Start Date
2/16/2026
Completion Date
5/17/2027
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
Eligibility Criteria
Age Range: No minimum to No maximum
Interventions
Ceftriaxon
Benzathine penicillin G
Conditions
Locations
Site 5048, USC - Maternal Child Adolescent/Adult Center
Los Angeles, California 90033
United States
Site 5112, David Geffen School of Medicine at UCLA NICHD CRS
Los Angeles, California 90095
United States
Site 5083, Rush Univ. Cook County Hosp. Chicago NICHD CRS
Chicago, Illinois 60612
United States
Site 4001, Lurie Children's Hospital of Chicago (LCH) CRS
Chicago, Illinois 60614
United States
Site 5040, SUNY Stony Brook NICHD CRS
Stony Brook, New York 11794
United States
Site 5114, Bronx-Lebanon Hospital Center NICHD CRS
The Bronx, New York 10457
United States
Site 5013, Jacobi Med. Ctr. Bronx NICHD CRS
The Bronx, New York 10461
United States
Site 5128, Baylor College of Medicine/Texas Children's Hospital NICHD CRS
Houston, Texas 77030
United States
Site 5129, IMPAACT/Gamma Project/UPR Pediatric HIV/AIDS Research CRS
San Juan, 00935
Puerto Rico