Study of Ceftriaxone and Benzathine Penicillin G During Pregnancy
Recruiting now
Conditions studied: Pregnancy
In brief
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.
Key facts
- Study ID
- NCT07207876
- Run by
- International Maternal Pediatric Adolescent AIDS Clinical Trials Group
- People needed
- 110
- Starts
- 2026-02-16
- Expected to finish
- 2027-09-30
- Last updated by the study team
- 2026-08-06
Who can join
Age: any. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Site 5129, IMPAACT/Gamma Project/UPR Pediatric HIV/AIDS Research CRS — San Juan, Puerto Rico (enrolling)
- Site 5112, David Geffen School of Medicine at UCLA NICHD CRS — Los Angeles, California, United States (enrolling)
- Site 5048, USC - Maternal Child Adolescent/Adult Center — Los Angeles, California, United States (enrolling)
- Site 4001, Lurie Children's Hospital of Chicago (LCH) CRS — Chicago, Illinois, United States (enrolling)
- Site 5040, SUNY Stony Brook NICHD CRS — Stony Brook, New York, United States (enrolling)
- Site 5114, Bronx-Lebanon Hospital Center NICHD CRS — The Bronx, New York, United States (enrolling)
- Site 5013, Jacobi Med. Ctr. Bronx NICHD CRS — The Bronx, New York, United States (enrolling)
- Site 5128, Baylor College of Medicine/Texas Children's Hospital NICHD CRS — Houston, Texas, United States (enrolling)
- Site 5083, Rush Univ. Cook County Hosp. Chicago NICHD CRS — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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