RecruitingNCT07207876

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

Sponsor

International Maternal Pediatric Adolescent AIDS Clinical Trials Group

Enrollment

110 participants

Start Date

Feb 16, 2026

Study Type

OBSERVATIONAL

Conditions

Pregnancy

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.

Eligibility

Sex: FEMALE

Inclusion Criteria6

Is of legal age or circumstance to provide independent informed consent as determined by site standard operating procedures (SOPs) and consistent with Institutional Review Board (IRB) policies and procedures and is willing and able to provide written informed consent for her own and, if applicable (Arm 2), her infant's study participation
At screening, has a viable singleton intrauterine pregnancy of any gestational age confirmed by fetal ultrasound, as determined by the site investigator based on medical records, with trimester documented based on the best available obstetric estimate
At screening, is receiving or expected to receive one of the following drugs under study as prescribed by a clinical care provider and documented in medical records:
Ceftriaxone: IV or IM administration for an indication other than syphilis
Benzathine penicillin G: IM administration for treatment of syphilis
At entry, expects to remain in the geographic area of the study site during pregnancy and at least 30 days postpartum

Exclusion Criteria28

Previously enrolled in this study
Requires desensitization to ceftriaxone or benzathine penicillin G as determined by the site investigator based on pregnant participant report and available medical records
Has any of the following as determined by the site investigator based on pregnant participant report and available medical records:
Current indication for hemodialysis
Current indication for intensive care unit hospitalization
Creatinine (Cr) ≥ 3.5 x upper limit of normal (ULN) at any time during the current pregnancy and/or chronic kidney disease Stage 5
Receipt of any of the following prohibited medications within seven days prior to entry as determined by the site investigator based on pregnant participant report and available medical records:
Probenecid
Penicillin
Arm 1A: any penicillin
Arm 1B: any penicillin
Arm 2: penicillin other than benzathine penicillin G
Benzapril
Chlorpropamide
Diflunisal
Irbesartan
Ketoprofen
Ketorolac tromethamine
Meclofenamic acid
Mefenamic acid
Oxaprozin
Parecoxib
Penciclovir
Pioglitazone
Telmisartan
Valsartan
Receipt of any investigational agent within seven days prior to entry as determined by the site investigator based on pregnant participant report and available medical records
Has any documented or suspected clinically significant condition that, in the opinion of the site investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving study objectives

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Interventions

DRUGCeftriaxon

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

DRUGBenzathine 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