NCT07207876 · International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Study of Ceftriaxone and Benzathine Penicillin G During Pregnancy
What this study is about
IMPAACT 2044 is a study to characterize the how the drug moves through the body (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.
View original scientific description
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.
Interventions
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
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
Primary outcome measures
Geometric mean area under the curve (AUC) during the dosing interval (AUC0-tau) in the first trimester trimester
Time frame: First on-study dose through 24 hours
Arm 1A
Geometric mean terminal elimination half-life (t1/2) in the first trimester
Time frame: First on-study dose through 24 hours
Arm 1A
Geometric mean trough concentration (Ctrough) in the first trimester
Time frame: First on-study dose through 24 hours
Arm 1A
Geometric mean AUC0-tau in the second trimester
Time frame: First on-study dose through 24 hours
Arm 1A
Geometric mean t1/2 in the second trimester
Time frame: First on-study dose through 24 hours
Arm 1A
Geometric mean Ctrough in the second trimester
Time frame: First on-study dose through 24 hours
Arm 1A
Geometric mean AUC0-tau in the third trimester
Time frame: First on-study dose through 24 hours
Arm 1A
Geometric mean t1/2 in the third trimester
Time frame: First on-study dose through 24 hours
Arm 1A
Geometric mean Ctrough in the third trimester
Time frame: First on-study dose through 24 hours
Arm 1A
Median maximum plasma concentration during the dose interval (Cmax) in the first trimester
Time frame: First on-study dose through up to 24 hours
Arm 1B
Median time to Cmax (Tmax) in the first trimester
Time frame: First on-study dose through up to 24 hours
Arm 1B
Median Cmax in the second trimester
Time frame: First on-study dose through up to 24 hours
Arm 1B
Median Tmax in the second trimester
Time frame: First on-study dose through up to 24 hours
Arm 1B
Median Cmax in the third trimester
Time frame: First on-study dose through up to 24 hours
Arm 1B
Median Tmax in the third trimester
Time frame: First on-study dose through up to 24 hours
Arm 1B
Geometric mean AUC at 7 days (AUC 0-7d) in the first trimester
Time frame: First on-study dose through 7 days
Arm 2
Geometric mean AUC at 14 days (AUC0-14d) in the first trimester
Time frame: First on-study dose through 14 days
Arm 2
Geometric mean plasma concentration at 2 hours (C2h) in the first trimester
Time frame: 2 hours post-first on-study dose
Arm 2
Geometric mean plasma concentration at 24 hours (C24h) in the first trimester
Time frame: 24 hours post-first on-study dose
Arm 2
Geometric mean plasma concentration at 4 days (C4d) in the first trimester
Time frame: 4 days post-first on-study dose
Arm 2
Geometric mean plasma concentration at 7 days (C7d) in the first trimester
Time frame: 7 days post-first on-study dose
Arm 2
Geometric mean plasma concentration at 14 days (C14d) in the first trimester
Time frame: 14 days post-first on-study dose
Arm 2
Geometric mean AUC0-7d in the second trimester
Time frame: First on-study dose through 7 days
Arm 2
Geometric mean AUC0-14d in the second trimester
Time frame: First on-study dose through 14 days
Arm 2
Geometric mean C2h in the second trimester
Time frame: 2 hours post-first on-study dose
Arm 2 (as defined above)
Geometric mean C24h in the second trimester
Time frame: 24 hours post-first on-study dose
Arm 2 (as defined above)
Geometric mean C4d in the second trimester
Time frame: 4 days post-first on-study dose
Arm 2 (as defined above)
Geometric mean C7d in the second trimester
Time frame: 7 days post-first on-study dose
Arm 2 (as defined above)
Geometric mean C14d in the second trimester
Time frame: 14 days post-first on-study dose
Arm 2 (as defined above)
Geometric mean AUC0-7d in the third trimester
Time frame: First on-study dose through 7 days
Arm 2
Geometric mean AUC0-14d in the third trimester
Time frame: First on-study dose through 14 days
Arm 2
Geometric mean C2h in the third trimester
Time frame: 2 hours post-first on-study dose
Arm 2 (as defined above)
Geometric mean C24h in the third trimester
Time frame: 24 hours post-first on-study dose
Arm 2 (as defined above)
Geometric mean C4d in the third trimester
Time frame: 4 days post-first on-study dose
Arm 2 (as defined above)
Geometric mean C7d in the third trimester
Time frame: 7 days post-first on-study dose
Arm 2 (as defined above)
Geometric mean C14d in the third trimester
Time frame: 14 days post-first on-study dose
Arm 2 (as defined above)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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:
- Arm 1A: any penicillin
- Arm 1B: any penicillin
- Arm 2: penicillin other than benzathine penicillin G
- Chlorpropamide
- Ketorolac tromethamine
- Meclofenamic acid
- Mefenamic acid
- Penciclovir
- Pioglitazone
- Telmisartan
- 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
Where
- Los Angeles, California
- Chicago, Illinois
- Stony Brook, New York
- The Bronx, New York
- Houston, Texas
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Mental Health (NIMH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 6, 2026 · Source of record for eligibility and locations