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.
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
Ceftriaxone: IV or IM administration for an indication other than syphilis
Benzathine penicillin G: IM administration for treatment of syphilis
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
Current indication for hemodialysis
Current indication for intensive care unit hospitalization
Women receiving or expecting to receive ceftriaxone for indications other than syphilis or benzathine penicillin G for treatment of syphilis during pregnancy in the United States (US). The infants of pregnant participants receiving benzathine penicillin G will also be enrolled.
Cohort
Prospective
Ceftriaxon
DrugCeftriaxone 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
DrugBenzathine 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
Geometric mean area under the curve (AUC) during the dosing interval (AUC0-tau) in the first trimester trimester
Arm 1A
Geometric mean terminal elimination half-life (t1/2) in the first trimester
Arm 1A
Geometric mean trough concentration (Ctrough) in the first trimester
Arm 1A
Geometric mean AUC0-tau in the second trimester
Arm 1A
Proportion of participants with a maternal serious adverse event (SAE)
Arm 1A and Arm 1B
Proportion of participants with a maternal SAE assessed as related to drug under study
Arm 1A and Arm 1B
Proportion of participants with a maternal SAE
Arm 2
Proportion of participants with a maternal SAE assessed as related to drug under study
Arm 2
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International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
National Institute of Mental Health (NIMH)
Collaborator
