Study of Ceftriaxone and Benzathine Penicillin G During Pregnancy
This observational study, called IMPAACT 2044, is looking at how two common antibiotics, ceftriaxone and benzathine penicillin G, behave in the bodies of pregnant women. Researchers want to understand the pharmacokinetics (PK), which is how the body absorbs, distributes, metabolizes, and excretes a drug, and the safety of these medications during pregnancy. You would be eligible if you are pregnant and are already receiving ceftriaxone for an infection other than syphilis, or benzathine penicillin G for syphilis, as prescribed by your regular doctor. The study aims to measure drug levels in your body during the first trimester. Up to 78 pregnant women and about 22 infants will participate. The study status is currently unclear.
- Study design
- This is an observational, open-label study, meaning both you and the researchers will know which treatment you are receiving. It plans to enroll up to 110 participants, including pregnant women and some of their infants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary measurements will be taken during the first trimester, specifically from the first dose through 24 hours.
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NCT07207876
Study of Ceftriaxone and Benzathine Penicillin G During Pregnancy
Recruiting
Not specifiedAll AgesObservationalInternational Maternal Pediatric Adolescent AIDS Clinical Trials GroupGovernment-funded
~110 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:CeftriaxonBenzathine penicillin G
At a glance
Recruiting sites
8 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Geometric mean area under the curve (AUC) during the dosing interval (AUC0-tau) in the first trimester trimester
Measured over First on-study dose through 24 hours
+35 more outcomes measured
Conditions
Where it's being run
9 sites across 5 statesNew York3
California2
Illinois2
Texas1
Puerto Rico1
Study leadership
- Jason Zucker · STUDY_CHAIR · Columbia Physicians & Surgeons (P&S) CRS
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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
What this trial measures
- Geometric mean area under the curve (AUC) during the dosing interval (AUC0-tau) in the first trimester trimesterFirst on-study dose through 24 hours
Arm 1A
- Geometric mean terminal elimination half-life (t1/2) in the first trimesterFirst on-study dose through 24 hours
Arm 1A
- Geometric mean trough concentration (Ctrough) in the first trimesterFirst on-study dose through 24 hours
Arm 1A
- Geometric mean AUC0-tau in the second trimesterFirst on-study dose through 24 hours
Arm 1A
- Geometric mean t1/2 in the second trimesterFirst on-study dose through 24 hours
Arm 1A
- Geometric mean Ctrough in the second trimesterFirst on-study dose through 24 hours
Arm 1A
- Geometric mean AUC0-tau in the third trimesterFirst on-study dose through 24 hours
Arm 1A
- Geometric mean t1/2 in the third trimesterFirst on-study dose through 24 hours
Arm 1A
- Geometric mean Ctrough in the third trimesterFirst on-study dose through 24 hours
Arm 1A
- Median maximum plasma concentration during the dose interval (Cmax) in the first trimesterFirst on-study dose through up to 24 hours
Arm 1B
- Median time to Cmax (Tmax) in the first trimesterFirst on-study dose through up to 24 hours
Arm 1B
- Median Cmax in the second trimesterFirst on-study dose through up to 24 hours
Arm 1B
- Median Tmax in the second trimesterFirst on-study dose through up to 24 hours
Arm 1B
- Median Cmax in the third trimesterFirst on-study dose through up to 24 hours
Arm 1B
- Median Tmax in the third trimesterFirst on-study dose through up to 24 hours
Arm 1B
- Geometric mean AUC at 7 days (AUC 0-7d) in the first trimesterFirst on-study dose through 7 days
Arm 2
- Geometric mean AUC at 14 days (AUC0-14d) in the first trimesterFirst on-study dose through 14 days
Arm 2
- Geometric mean plasma concentration at 2 hours (C2h) in the first trimester2 hours post-first on-study dose
Arm 2
- Geometric mean plasma concentration at 24 hours (C24h) in the first trimester24 hours post-first on-study dose
Arm 2
- Geometric mean plasma concentration at 4 days (C4d) in the first trimester4 days post-first on-study dose
Arm 2
- Geometric mean plasma concentration at 7 days (C7d) in the first trimester7 days post-first on-study dose
Arm 2
- Geometric mean plasma concentration at 14 days (C14d) in the first trimester14 days post-first on-study dose
Arm 2
- Geometric mean AUC0-7d in the second trimesterFirst on-study dose through 7 days
Arm 2
- Geometric mean AUC0-14d in the second trimesterFirst on-study dose through 14 days
Arm 2
- Geometric mean C2h in the second trimester2 hours post-first on-study dose
Arm 2 (as defined above)
- Geometric mean C24h in the second trimester24 hours post-first on-study dose
Arm 2 (as defined above)
- Geometric mean C4d in the second trimester4 days post-first on-study dose
Arm 2 (as defined above)
- Geometric mean C7d in the second trimester7 days post-first on-study dose
Arm 2 (as defined above)
- Geometric mean C14d in the second trimester14 days post-first on-study dose
Arm 2 (as defined above)
- Geometric mean AUC0-7d in the third trimesterFirst on-study dose through 7 days
Arm 2
- Geometric mean AUC0-14d in the third trimesterFirst on-study dose through 14 days
Arm 2
- Geometric mean C2h in the third trimester2 hours post-first on-study dose
Arm 2 (as defined above)
- Geometric mean C24h in the third trimester24 hours post-first on-study dose
Arm 2 (as defined above)
- Geometric mean C4d in the third trimester4 days post-first on-study dose
Arm 2 (as defined above)
- Geometric mean C7d in the third trimester7 days post-first on-study dose
Arm 2 (as defined above)
- Geometric mean C14d in the third trimester14 days post-first on-study dose
Arm 2 (as defined above)