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RECRUITING
NCT07207876

Study of Ceftriaxone and Benzathine Penicillin G During Pregnancy

Sponsor: International Maternal Pediatric Adolescent AIDS Clinical Trials Group

View on ClinicalTrials.gov

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

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

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