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.
IMPAACT 2044 is a Phase IV, multi-site, open-label, non-randomized, opportunistic study to characterize the pharmacokinetics (PK) and safety of ceftriaxone and benzathine penicillin G during pregnancy. The study includes two arms, with Arm 1 subdivided by route of administration: Arm 1A: Intravenous (IV) ceftriaxone Arm 1B: Intramuscular (IM) ceftriaxone Arm 2: IM benzathine penicillin G
Study Type
OBSERVATIONAL
Enrollment
110
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 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
Site 5048, USC - Maternal Child Adolescent/Adult Center
Los Angeles, California, United States
RECRUITINGSite 5112, David Geffen School of Medicine at UCLA NICHD CRS
Los Angeles, California, United States
RECRUITINGSite 5083, Rush Univ. Cook County Hosp. Chicago NICHD CRS
Chicago, Illinois, United States
NOT_YET_RECRUITINGSite 4001, Lurie Children's Hospital of Chicago (LCH) CRS
Chicago, Illinois, United States
RECRUITINGSite 5040, SUNY Stony Brook NICHD CRS
Stony Brook, New York, United States
RECRUITINGSite 5114, Bronx-Lebanon Hospital Center NICHD CRS
The Bronx, New York, United States
RECRUITINGSite 5013, Jacobi Med. Ctr. Bronx NICHD CRS
The Bronx, New York, United States
RECRUITINGSite 5128, Baylor College of Medicine/Texas Children's Hospital NICHD CRS
Houston, Texas, United States
RECRUITINGSite 5129, IMPAACT/Gamma Project/UPR Pediatric HIV/AIDS Research CRS
San Juan, Puerto Rico
RECRUITINGGeometric mean area under the curve (AUC) during the dosing interval (AUC0-tau) in the first trimester trimester
Arm 1A
Time frame: First on-study dose through 24 hours
Geometric mean terminal elimination half-life (t1/2) in the first trimester
Arm 1A
Time frame: First on-study dose through 24 hours
Geometric mean trough concentration (Ctrough) in the first trimester
Arm 1A
Time frame: First on-study dose through 24 hours
Geometric mean AUC0-tau in the second trimester
Arm 1A
Time frame: First on-study dose through 24 hours
Geometric mean t1/2 in the second trimester
Arm 1A
Time frame: First on-study dose through 24 hours
Geometric mean Ctrough in the second trimester
Arm 1A
Time frame: First on-study dose through 24 hours
Geometric mean AUC0-tau in the third trimester
Arm 1A
Time frame: First on-study dose through 24 hours
Geometric mean t1/2 in the third trimester
Arm 1A
Time frame: First on-study dose through 24 hours
Geometric mean Ctrough in the third trimester
Arm 1A
Time frame: First on-study dose through 24 hours
Median maximum plasma concentration during the dose interval (Cmax) in the first trimester
Arm 1B
Time frame: First on-study dose through up to 24 hours
Median time to Cmax (Tmax) in the first trimester
Arm 1B
Time frame: First on-study dose through up to 24 hours
Median Cmax in the second trimester
Arm 1B
Time frame: First on-study dose through up to 24 hours
Median Tmax in the second trimester
Arm 1B
Time frame: First on-study dose through up to 24 hours
Median Cmax in the third trimester
Arm 1B
Time frame: First on-study dose through up to 24 hours
Median Tmax in the third trimester
Arm 1B
Time frame: First on-study dose through up to 24 hours
Geometric mean AUC at 7 days (AUC 0-7d) in the first trimester
Arm 2
Time frame: First on-study dose through 7 days
Geometric mean AUC at 14 days (AUC0-14d) in the first trimester
Arm 2
Time frame: First on-study dose through 14 days
Geometric mean plasma concentration at 2 hours (C2h) in the first trimester
Arm 2
Time frame: 2 hours post-first on-study dose
Geometric mean plasma concentration at 24 hours (C24h) in the first trimester
Arm 2
Time frame: 24 hours post-first on-study dose
Geometric mean plasma concentration at 4 days (C4d) in the first trimester
Arm 2
Time frame: 4 days post-first on-study dose
Geometric mean plasma concentration at 7 days (C7d) in the first trimester
Arm 2
Time frame: 7 days post-first on-study dose
Geometric mean plasma concentration at 14 days (C14d) in the first trimester
Arm 2
Time frame: 14 days post-first on-study dose
Geometric mean AUC0-7d in the second trimester
Arm 2
Time frame: First on-study dose through 7 days
Geometric mean AUC0-14d in the second trimester
Arm 2
Time frame: First on-study dose through 14 days
Geometric mean C2h in the second trimester
Arm 2 (as defined above)
Time frame: 2 hours post-first on-study dose
Geometric mean C24h in the second trimester
Arm 2 (as defined above)
Time frame: 24 hours post-first on-study dose
Geometric mean C4d in the second trimester
Arm 2 (as defined above)
Time frame: 4 days post-first on-study dose
Geometric mean C7d in the second trimester
Arm 2 (as defined above)
Time frame: 7 days post-first on-study dose
Geometric mean C14d in the second trimester
Arm 2 (as defined above)
Time frame: 14 days post-first on-study dose
Geometric mean AUC0-7d in the third trimester
Arm 2
Time frame: First on-study dose through 7 days
Geometric mean AUC0-14d in the third trimester
Arm 2
Time frame: First on-study dose through 14 days
Geometric mean C2h in the third trimester
Arm 2 (as defined above)
Time frame: 2 hours post-first on-study dose
Geometric mean C24h in the third trimester
Arm 2 (as defined above)
Time frame: 24 hours post-first on-study dose
Geometric mean C4d in the third trimester
Arm 2 (as defined above)
Time frame: 4 days post-first on-study dose
Geometric mean C7d in the third trimester
Arm 2 (as defined above)
Time frame: 7 days post-first on-study dose
Geometric mean C14d in the third trimester
Arm 2 (as defined above)
Time frame: 14 days post-first on-study dose
Proportion of participants with a maternal serious adverse event (SAE)
Arm 1A and Arm 1B
Time frame: First on-study dose through 7 days
Proportion of participants with a maternal SAE assessed as related to drug under study
Arm 1A and Arm 1B
Time frame: First on-study dose through 7 days
Proportion of participants with a maternal SAE
Arm 2
Time frame: First on-study dose through up to 28 days
Proportion of participants with a maternal SAE assessed as related to drug under study
Arm 2
Time frame: First on-study dose through up to 28 days
Proportion of participants with a spontaneous abortion or miscarriage (<20 weeks gestation)
Arm 1A, Arm1B, and Arm 2
Time frame: At pregnancy outcome/delivery/birth
Proportion of participants with a stillbirth (≥20 weeks gestation)
Arm 1A, Arm1B, and Arm 2
Time frame: At pregnancy outcome/delivery/birth
Proportion of participants with an infant small for gestational age (SGA; weight <10th percentile for gestational age, adjusted for sex)
Arm 1A, Arm1B, and Arm 2
Time frame: At pregnancy outcome/delivery/birth
Proportion of participants with a preterm birth (<37 weeks gestation)
Arm 1A, Arm1B, and Arm 2
Time frame: At pregnancy outcome/delivery/birth
Proportion of participants with an infant congenital anomaly consistent with the definition of defect provided by Metropolitan Atlanta Congenital Defects Program (MACDP)
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Arm 1A, Arm1B, and Arm 2
Time frame: At pregnancy outcome/delivery/birth