Actively Recruiting
Study of Ceftriaxone and Benzathine Penicillin G During Pregnancy
Led by International Maternal Pediatric Adolescent AIDS Clinical Trials Group · Updated on 2026-03-27
110
Participants Needed
9
Research Sites
65 weeks
Total Duration
On this page
Sponsors
I
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Lead Sponsor
N
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of Ceftriaxone and Benzathine Penicillin G During Pregnancy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide informed consent for self and infant if applicable
- Pregnant with a viable singleton intrauterine pregnancy at any gestational age confirmed by ultrasound
- Currently receiving or expected to receive ceftriaxone (IV or IM) for non-syphilis reasons or benzathine penicillin G (IM) for syphilis treatment
- Plans to remain in the study area during pregnancy and at least 30 days postpartum
You will not qualify if you...
- Previously enrolled in this study
- Needs desensitization to ceftriaxone or benzathine penicillin G
- Has current need for hemodialysis or intensive care unit hospitalization
- Has creatinine levels 3.5 times above normal or stage 5 chronic kidney disease during current pregnancy
- Received prohibited medications within 7 days before entry, including probenecid, penicillin (except benzathine penicillin G for Arm 2), benzapril, chlorpropamide, diflunisal, irbesartan, ketoprofen, ketorolac tromethamine, meclofenamic acid, mefenamic acid, oxaprozin, parecoxib, penciclovir, pioglitazone, telmisartan, or valsartan
- Received any investigational drug within 7 days before entry
- Has any significant medical condition that makes participation unsafe or would interfere with study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
Site 5048, USC - Maternal Child Adolescent/Adult Center
Los Angeles, California, United States, 90033
Not Yet Recruiting
2
Site 5112, David Geffen School of Medicine at UCLA NICHD CRS
Los Angeles, California, United States, 90095
Actively Recruiting
3
Site 5083, Rush Univ. Cook County Hosp. Chicago NICHD CRS
Chicago, Illinois, United States, 60612
Not Yet Recruiting
4
Site 4001, Lurie Children's Hospital of Chicago (LCH) CRS
Chicago, Illinois, United States, 60614
Actively Recruiting
5
Site 5040, SUNY Stony Brook NICHD CRS
Stony Brook, New York, United States, 11794
Actively Recruiting
6
Site 5114, Bronx-Lebanon Hospital Center NICHD CRS
The Bronx, New York, United States, 10457
Actively Recruiting
7
Site 5013, Jacobi Med. Ctr. Bronx NICHD CRS
The Bronx, New York, United States, 10461
Not Yet Recruiting
8
Site 5128, Baylor College of Medicine/Texas Children's Hospital NICHD CRS
Houston, Texas, United States, 77030
Not Yet Recruiting
9
Site 5129, IMPAACT/Gamma Project/UPR Pediatric HIV/AIDS Research CRS
San Juan, Puerto Rico, 00935
Not Yet Recruiting
Research Team
L
Lisa Levy
CONTACT
L
Lisa Levy
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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