NCT07207876 Study of Ceftriaxone and Benzathine Penicillin G During Pregnancy
| NCT ID | NCT07207876 |
| Status | Recruiting |
| Phase | — |
| Sponsor | International Maternal Pediatric Adolescent AIDS Clinical Trials Group |
| Condition | Pregnancy |
| Study Type | OBSERVATIONAL |
| Enrollment | 110 participants |
| Start Date | 2026-02-16 |
| Primary Completion | 2027-01-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 110 participants in total. It began in 2026-02-16 with a primary completion date of 2027-01-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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: * 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
Contact & Investigator
Jason Zucker
STUDY CHAIR
Columbia Physicians & Surgeons (P&S) CRS
Frequently Asked Questions
Who can join the NCT07207876 clinical trial?
This trial is open to female participants only, studying Pregnancy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07207876 currently recruiting?
Yes, NCT07207876 is actively recruiting participants. Contact the research team at impaact.ctgov@fstrf.org for enrollment information.
Where is the NCT07207876 trial being conducted?
This trial is being conducted at Los Angeles, United States, Los Angeles, United States, Chicago, United States, Chicago, United States and 5 additional locations.
Who is sponsoring the NCT07207876 clinical trial?
NCT07207876 is sponsored by International Maternal Pediatric Adolescent AIDS Clinical Trials Group. The principal investigator is Jason Zucker at Columbia Physicians & Surgeons (P&S) CRS. The trial plans to enroll 110 participants.