Phase IV Study of the Pharmacokinetics and Safety of Ceftriaxone and Benzathine Penicillin G During Pregnancy
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Summary
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.
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
Eligibility
- Age range
- Not specified
- Sex
- Female
- 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 o…
Interventions
- DrugCeftriaxon
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
- DrugBenzathine 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
Locations (9)
- Site 5048, USC - Maternal Child Adolescent/Adult CenterLos Angeles, California
- Site 5112, David Geffen School of Medicine at UCLA NICHD CRSLos Angeles, California
- Site 5083, Rush Univ. Cook County Hosp. Chicago NICHD CRSChicago, Illinois
- Site 4001, Lurie Children's Hospital of Chicago (LCH) CRSChicago, Illinois
- Site 5040, SUNY Stony Brook NICHD CRSStony Brook, New York
- Site 5114, Bronx-Lebanon Hospital Center NICHD CRSThe Bronx, New York