Study of Ceftriaxone and Benzathine Penicillin G During Pregnancy

Purpose

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.

Condition

  • Pregnancy

Eligibility

Eligible Ages
All ages
Eligible Sex
Female
Accepts Healthy Volunteers
No

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

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Active comparator: Arm 1A: IV ceftriaxone Intravenous ceftriaxone
  • Drug: Ceftriaxon
    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
Active Comparator: Arm 1B: IM ceftriaxone Intramuscular ceftriaxone
  • Drug: Ceftriaxon
    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
Active Comparator: Arm 2: IM benzathine penicillin G Intramuscular benzathine penicillin G
  • Drug: Benzathine 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

Recruiting Locations

Site 4001, Lurie Children's Hospital of Chicago (LCH) CRS
Chicago 4887398, Illinois 4896861 60614
Contact:
Jennifer Jao
312-227-4080
JJao@luriechildrens.org

Site 5114, Bronx-Lebanon Hospital Center NICHD CRS
The Bronx 5110266, New York 5128638 10457
Contact:
Murli Purswani
718-960-1010
mpurswan@bronxcare.org

More Details

Status
Recruiting
Sponsor
International Maternal Pediatric Adolescent AIDS Clinical Trials Group

Study Contact

Lisa Levy
2028848480
impaact.ctgov@fstrf.org

Detailed Description

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