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NCT07207876Recruiting

Study of Ceftriaxone and Benzathine Penicillin G During Pregnancy

International Maternal Pediatric Adolescent AIDS Clinical Trials Group

Start Date

2/16/2026

Completion Date

5/17/2027

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.

Detailed Description

IMPAACT 2044 is a Phase IV, multi-site, open-label, non-randomized, opportunistic study to characterize the pharmacokinetics (PK) and safety of ceftriaxone and benzathine penicillin G during pregnancy. The study includes two arms, with Arm 1 subdivided by route of administration: Arm 1A: Intravenous (IV) ceftriaxone Arm 1B: Intramuscular (IM) ceftriaxone Arm 2: IM benzathine penicillin G

Eligibility Criteria

Age Range: No minimum to No maximum

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

Interventions

DRUG

Ceftriaxon

DRUG

Benzathine penicillin G

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Conditions

Pregnancy

Locations

Site 5048, USC - Maternal Child Adolescent/Adult Center

Los Angeles, California 90033

United States

Site 5112, David Geffen School of Medicine at UCLA NICHD CRS

Los Angeles, California 90095

United States

Site 5083, Rush Univ. Cook County Hosp. Chicago NICHD CRS

Chicago, Illinois 60612

United States

Site 4001, Lurie Children's Hospital of Chicago (LCH) CRS

Chicago, Illinois 60614

United States

Site 5040, SUNY Stony Brook NICHD CRS

Stony Brook, New York 11794

United States

Site 5114, Bronx-Lebanon Hospital Center NICHD CRS

The Bronx, New York 10457

United States

Site 5013, Jacobi Med. Ctr. Bronx NICHD CRS

The Bronx, New York 10461

United States

Site 5128, Baylor College of Medicine/Texas Children's Hospital NICHD CRS

Houston, Texas 77030

United States

Site 5129, IMPAACT/Gamma Project/UPR Pediatric HIV/AIDS Research CRS

San Juan, 00935

Puerto Rico