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.
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Geometric mean area under the curve (AUC) during the dosing interval (AUC0-tau) in the first trimester trimester
Timeframe: First on-study dose through 24 hours
Geometric mean terminal elimination half-life (t1/2) in the first trimester
Timeframe: First on-study dose through 24 hours
Geometric mean trough concentration (Ctrough) in the first trimester
Timeframe: First on-study dose through 24 hours
Geometric mean AUC0-tau in the second trimester
Timeframe: First on-study dose through 24 hours
Geometric mean t1/2 in the second trimester
Timeframe: First on-study dose through 24 hours
Geometric mean Ctrough in the second trimester
Timeframe: First on-study dose through 24 hours
Geometric mean AUC0-tau in the third trimester
Timeframe: First on-study dose through 24 hours
Geometric mean t1/2 in the third trimester
Timeframe: First on-study dose through 24 hours
Geometric mean Ctrough in the third trimester
Timeframe: First on-study dose through 24 hours
Median maximum plasma concentration during the dose interval (Cmax) in the first trimester
Timeframe: First on-study dose through up to 24 hours
Median time to Cmax (Tmax) in the first trimester
Timeframe: First on-study dose through up to 24 hours
Median Cmax in the second trimester
Timeframe: First on-study dose through up to 24 hours
Median Tmax in the second trimester
Timeframe: First on-study dose through up to 24 hours
Median Cmax in the third trimester
Timeframe: First on-study dose through up to 24 hours
Median Tmax in the third trimester
Timeframe: First on-study dose through up to 24 hours
Geometric mean AUC at 7 days (AUC 0-7d) in the first trimester
Timeframe: First on-study dose through 7 days
Geometric mean AUC at 14 days (AUC0-14d) in the first trimester
Timeframe: First on-study dose through 14 days
Geometric mean plasma concentration at 2 hours (C2h) in the first trimester
Timeframe: 2 hours post-first on-study dose
Geometric mean plasma concentration at 24 hours (C24h) in the first trimester
Timeframe: 24 hours post-first on-study dose
Geometric mean plasma concentration at 4 days (C4d) in the first trimester
Timeframe: 4 days post-first on-study dose
Geometric mean plasma concentration at 7 days (C7d) in the first trimester
Timeframe: 7 days post-first on-study dose
Geometric mean plasma concentration at 14 days (C14d) in the first trimester
Timeframe: 14 days post-first on-study dose
Geometric mean AUC0-7d in the second trimester
Timeframe: First on-study dose through 7 days
Geometric mean AUC0-14d in the second trimester
Timeframe: First on-study dose through 14 days
Geometric mean C2h in the second trimester
Timeframe: 2 hours post-first on-study dose
Geometric mean C24h in the second trimester
Timeframe: 24 hours post-first on-study dose
Geometric mean C4d in the second trimester
Timeframe: 4 days post-first on-study dose
Geometric mean C7d in the second trimester
Timeframe: 7 days post-first on-study dose
Geometric mean C14d in the second trimester
Timeframe: 14 days post-first on-study dose
Geometric mean AUC0-7d in the third trimester
Timeframe: First on-study dose through 7 days
Geometric mean AUC0-14d in the third trimester
Timeframe: First on-study dose through 14 days
Geometric mean C2h in the third trimester
Timeframe: 2 hours post-first on-study dose
Geometric mean C24h in the third trimester
Timeframe: 24 hours post-first on-study dose
Geometric mean C4d in the third trimester
Timeframe: 4 days post-first on-study dose
Geometric mean C7d in the third trimester
Timeframe: 7 days post-first on-study dose
Geometric mean C14d in the third trimester
Timeframe: 14 days post-first on-study dose