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NCT Number: NCT07207876

Study of Ceftriaxone and Benzathine Penicillin G During Pregnancy

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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Key information

Conditions

Pregnancy Bacterial Infections Bacterial Infections and Mycoses Communicable Diseases Genital Diseases Gram-Negative Bacterial Infections Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Bacterial Spirochaetales Infections Syphilis Treponemal Infections Urogenital Diseases

Sex eligibility

Female

Study type

Observational

Primary location

Site 5129, IMPAACT/Gamma Project/UPR Pediatric HIV/AIDS Research CRS, San Juan, Puerto Rico

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Ceftriaxon

Drug

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

Drug

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

Primary outcomes

  1. Geometric mean area under the curve (AUC) during the dosing interval (AUC0-tau) in the first trimester trimester

    Time frame: First on-study dose through 24 hours

    Arm 1A

  2. Geometric mean terminal elimination half-life (t1/2) in the first trimester

    Time frame: First on-study dose through 24 hours

    Arm 1A

  3. Geometric mean trough concentration (Ctrough) in the first trimester

    Time frame: First on-study dose through 24 hours

    Arm 1A

  4. Geometric mean AUC0-tau in the second trimester

    Time frame: First on-study dose through 24 hours

    Arm 1A

  5. Geometric mean t1/2 in the second trimester

    Time frame: First on-study dose through 24 hours

    Arm 1A

  6. Geometric mean Ctrough in the second trimester

    Time frame: First on-study dose through 24 hours

    Arm 1A

  7. Geometric mean AUC0-tau in the third trimester

    Time frame: First on-study dose through 24 hours

    Arm 1A

  8. Geometric mean t1/2 in the third trimester

    Time frame: First on-study dose through 24 hours

    Arm 1A

  9. Geometric mean Ctrough in the third trimester

    Time frame: First on-study dose through 24 hours

    Arm 1A

  10. Median maximum plasma concentration during the dose interval (Cmax) in the first trimester

    Time frame: First on-study dose through up to 24 hours

    Arm 1B

  11. Median time to Cmax (Tmax) in the first trimester

    Time frame: First on-study dose through up to 24 hours

    Arm 1B

  12. Median Cmax in the second trimester

    Time frame: First on-study dose through up to 24 hours

    Arm 1B

  13. Median Tmax in the second trimester

    Time frame: First on-study dose through up to 24 hours

    Arm 1B

  14. Median Cmax in the third trimester

    Time frame: First on-study dose through up to 24 hours

    Arm 1B

  15. Median Tmax in the third trimester

    Time frame: First on-study dose through up to 24 hours

    Arm 1B

  16. Geometric mean AUC at 7 days (AUC 0-7d) in the first trimester

    Time frame: First on-study dose through 7 days

    Arm 2

  17. Geometric mean AUC at 14 days (AUC0-14d) in the first trimester

    Time frame: First on-study dose through 14 days

    Arm 2

  18. Geometric mean plasma concentration at 2 hours (C2h) in the first trimester

    Time frame: 2 hours post-first on-study dose

    Arm 2

  19. Geometric mean plasma concentration at 24 hours (C24h) in the first trimester

    Time frame: 24 hours post-first on-study dose

    Arm 2

  20. Geometric mean plasma concentration at 4 days (C4d) in the first trimester

    Time frame: 4 days post-first on-study dose

    Arm 2

  21. Geometric mean plasma concentration at 7 days (C7d) in the first trimester

    Time frame: 7 days post-first on-study dose

    Arm 2

  22. Geometric mean plasma concentration at 14 days (C14d) in the first trimester

    Time frame: 14 days post-first on-study dose

    Arm 2

  23. Geometric mean AUC0-7d in the second trimester

    Time frame: First on-study dose through 7 days

    Arm 2

  24. Geometric mean AUC0-14d in the second trimester

    Time frame: First on-study dose through 14 days

    Arm 2

  25. Geometric mean C2h in the second trimester

    Time frame: 2 hours post-first on-study dose

    Arm 2 (as defined above)

  26. Geometric mean C24h in the second trimester

    Time frame: 24 hours post-first on-study dose

    Arm 2 (as defined above)

  27. Geometric mean C4d in the second trimester

    Time frame: 4 days post-first on-study dose

    Arm 2 (as defined above)

  28. Geometric mean C7d in the second trimester

    Time frame: 7 days post-first on-study dose

    Arm 2 (as defined above)

  29. Geometric mean C14d in the second trimester

    Time frame: 14 days post-first on-study dose

    Arm 2 (as defined above)

  30. Geometric mean AUC0-7d in the third trimester

    Time frame: First on-study dose through 7 days

    Arm 2

  31. Geometric mean AUC0-14d in the third trimester

    Time frame: First on-study dose through 14 days

    Arm 2

  32. Geometric mean C2h in the third trimester

    Time frame: 2 hours post-first on-study dose

    Arm 2 (as defined above)

  33. Geometric mean C24h in the third trimester

    Time frame: 24 hours post-first on-study dose

    Arm 2 (as defined above)

  34. Geometric mean C4d in the third trimester

    Time frame: 4 days post-first on-study dose

    Arm 2 (as defined above)

  35. Geometric mean C7d in the third trimester

    Time frame: 7 days post-first on-study dose

    Arm 2 (as defined above)

  36. Geometric mean C14d in the third trimester

    Time frame: 14 days post-first on-study dose

    Arm 2 (as defined above)

Secondary outcomes

  1. Proportion of participants with a maternal serious adverse event (SAE)

    Time frame: First on-study dose through 7 days

    Arm 1A and Arm 1B

  2. Proportion of participants with a maternal SAE assessed as related to drug under study

    Time frame: First on-study dose through 7 days

    Arm 1A and Arm 1B

  3. Proportion of participants with a maternal SAE

    Time frame: First on-study dose through up to 28 days

    Arm 2

  4. Proportion of participants with a maternal SAE assessed as related to drug under study

    Time frame: First on-study dose through up to 28 days

    Arm 2

  5. Proportion of participants with a spontaneous abortion or miscarriage (<20 weeks gestation)

    Time frame: At pregnancy outcome/delivery/birth

    Arm 1A, Arm1B, and Arm 2

  6. Proportion of participants with a stillbirth (≥20 weeks gestation)

    Time frame: At pregnancy outcome/delivery/birth

    Arm 1A, Arm1B, and Arm 2

  7. Proportion of participants with an infant small for gestational age (SGA; weight <10th percentile for gestational age, adjusted for sex)

    Time frame: At pregnancy outcome/delivery/birth

    Arm 1A, Arm1B, and Arm 2

  8. Proportion of participants with a preterm birth (<37 weeks gestation)

    Time frame: At pregnancy outcome/delivery/birth

    Arm 1A, Arm1B, and Arm 2

  9. Proportion of participants with an infant congenital anomaly consistent with the definition of defect provided by Metropolitan Atlanta Congenital Defects Program (MACDP)

    Time frame: At pregnancy outcome/delivery/birth

    Arm 1A, Arm1B, and Arm 2

Study contacts

Contact information is provided by the study sponsor or research team.

Lisa Levy

CONTACT

[email protected]

2028848480

Lisa Levy

CONTACT

[email protected]

2028848480

Sponsors and collaborators

Lead sponsor

International Maternal Pediatric Adolescent AIDS Clinical Trials Group

Network

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Phase IV Study of the Pharmacokinetics and Safety of Ceftriaxone and Benzathine Penicillin G During Pregnancy

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Oct 6, 2025
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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