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Study of Ceftriaxone and Benzathine Penicillin G During Pregnancy
Sponsor: International Maternal Pediatric Adolescent AIDS Clinical Trials Group
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.
Official title: Phase IV Study of the Pharmacokinetics and Safety of Ceftriaxone and Benzathine Penicillin G During Pregnancy
Key Details
Gender
FEMALE
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
110
Start Date
2026-02-16
Completion Date
2027-05-17
Last Updated
2026-03-27
Healthy Volunteers
No
Conditions
Interventions
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
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
Locations (9)
Site 5048, USC - Maternal Child Adolescent/Adult Center
Los Angeles, California, United States
Site 5112, David Geffen School of Medicine at UCLA NICHD CRS
Los Angeles, California, United States
Site 5083, Rush Univ. Cook County Hosp. Chicago NICHD CRS
Chicago, Illinois, United States
Site 4001, Lurie Children's Hospital of Chicago (LCH) CRS
Chicago, Illinois, United States
Site 5040, SUNY Stony Brook NICHD CRS
Stony Brook, New York, United States
Site 5114, Bronx-Lebanon Hospital Center NICHD CRS
The Bronx, New York, United States
Site 5013, Jacobi Med. Ctr. Bronx NICHD CRS
The Bronx, New York, United States
Site 5128, Baylor College of Medicine/Texas Children's Hospital NICHD CRS
Houston, Texas, United States
Site 5129, IMPAACT/Gamma Project/UPR Pediatric HIV/AIDS Research CRS
San Juan, Puerto Rico