Recruiting

Ceftriaxone & Benzathine Penicillin G

Sponsor:

International Maternal Pediatric Adolescent AIDS Clinical Trials Group

Code:

NCT07207876

Conditions

Pregnancy

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Ceftriaxon

Benzathine penicillin G

Study Details

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.

Conditions

Pregnancy

Study ID

NCT07207876

Start date

Feb 16, 2026

Status verified date

Aug, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Jan 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

110 participants

Anticipated

Interventions and Outcome Measures

Arms

Active comparator: Arm 1A: IV ceftriaxone

Intravenous ceftriaxone

Active Comparator: Arm 1B: IM ceftriaxone

Intramuscular ceftriaxone

Active Comparator: Arm 2: IM benzathine penicillin G

Intramuscular benzathine penicillin G

Interventions

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

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 measure

  • 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 ]
  • Geometric mean terminal elimination half-life (t1/2) in the first trimester [ Time Frame: First on-study dose through 24 hours ]
  • Geometric mean trough concentration (Ctrough) in the first trimester [ Time Frame: First on-study dose through 24 hours ]
  • Geometric mean AUC0-tau in the second trimester [ Time Frame: First on-study dose through 24 hours ]
  • Geometric mean t1/2 in the second trimester [ Time Frame: First on-study dose through 24 hours ]
  • Geometric mean Ctrough in the second trimester [ Time Frame: First on-study dose through 24 hours ]
  • Geometric mean AUC0-tau in the third trimester [ Time Frame: First on-study dose through 24 hours ]
  • Geometric mean t1/2 in the third trimester [ Time Frame: First on-study dose through 24 hours ]
  • Geometric mean Ctrough in the third trimester [ Time Frame: First on-study dose through 24 hours ]
  • Median maximum plasma concentration during the dose interval (Cmax) in the first trimester [ Time Frame: First on-study dose through up to 24 hours ]
  • Median time to Cmax (Tmax) in the first trimester [ Time Frame: First on-study dose through up to 24 hours ]
  • Median Cmax in the second trimester [ Time Frame: First on-study dose through up to 24 hours ]
  • Median Tmax in the second trimester [ Time Frame: First on-study dose through up to 24 hours ]
  • Median Cmax in the third trimester [ Time Frame: First on-study dose through up to 24 hours ]
  • Median Tmax in the third trimester [ Time Frame: First on-study dose through up to 24 hours ]
  • Geometric mean AUC at 7 days (AUC 0-7d) in the first trimester [ Time Frame: First on-study dose through 7 days ]
  • Geometric mean AUC at 14 days (AUC0-14d) in the first trimester [ Time Frame: First on-study dose through 14 days ]
  • Geometric mean plasma concentration at 2 hours (C2h) in the first trimester [ Time Frame: 2 hours post-first on-study dose ]
  • Geometric mean plasma concentration at 24 hours (C24h) in the first trimester [ Time Frame: 24 hours post-first on-study dose ]
  • Geometric mean plasma concentration at 4 days (C4d) in the first trimester [ Time Frame: 4 days post-first on-study dose ]
  • Geometric mean plasma concentration at 7 days (C7d) in the first trimester [ Time Frame: 7 days post-first on-study dose ]
  • Geometric mean plasma concentration at 14 days (C14d) in the first trimester [ Time Frame: 14 days post-first on-study dose ]
  • Geometric mean AUC0-7d in the second trimester [ Time Frame: First on-study dose through 7 days ]
  • Geometric mean AUC0-14d in the second trimester [ Time Frame: First on-study dose through 14 days ]
  • Geometric mean C2h in the second trimester [ Time Frame: 2 hours post-first on-study dose ]
  • Geometric mean C24h in the second trimester [ Time Frame: 24 hours post-first on-study dose ]
  • Geometric mean C4d in the second trimester [ Time Frame: 4 days post-first on-study dose ]
  • Geometric mean C7d in the second trimester [ Time Frame: 7 days post-first on-study dose ]
  • Geometric mean C14d in the second trimester [ Time Frame: 14 days post-first on-study dose ]
  • Geometric mean AUC0-7d in the third trimester [ Time Frame: First on-study dose through 7 days ]
  • Geometric mean AUC0-14d in the third trimester [ Time Frame: First on-study dose through 14 days ]
  • Geometric mean C2h in the third trimester [ Time Frame: 2 hours post-first on-study dose ]
  • Geometric mean C24h in the third trimester [ Time Frame: 24 hours post-first on-study dose ]
  • Geometric mean C4d in the third trimester [ Time Frame: 4 days post-first on-study dose ]
  • Geometric mean C7d in the third trimester [ Time Frame: 7 days post-first on-study dose ]
  • Geometric mean C14d in the third trimester [ Time Frame: 14 days post-first on-study dose ]

Central Contacts and Locations

Central contacts

Lisa Levy

2028848480impaact.ctgov@fstrf.org

Lisa Levy

2028848480llevy@fhi360.org

Locations

Site 5048, USC - Maternal Child Adolescent/Adult Center

Recruiting

Los Angeles, California, United States, 90033

Contacts

Alice Stek

323-865-1585stek@usc.edu

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

Recruiting

Los Angeles, California, United States, 90095

Contacts

Jaime Deville

310-825-9660jdeville@mednet.ucla.edu

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

Recruiting

Chicago, Illinois, United States, 60614

Contacts

Jennifer Jao

312-227-4080JJao@luriechildrens.org

Site 5040, SUNY Stony Brook NICHD CRS

Recruiting

Stony Brook, New York, United States, 11794

Contacts

Sharon Nachman

631-444-7692sharon.nachman@stonybrookmedicine.edu

Site 5114, Bronx-Lebanon Hospital Center NICHD CRS

Recruiting

The Bronx, New York, United States, 10457

Contacts

Murli Purswani

718-960-1010mpurswan@bronxcare.org

Site 5013, Jacobi Med. Ctr. Bronx NICHD CRS

Recruiting

The Bronx, New York, United States, 10461

Contacts

Andrew Wiznia

718-918-4664andrew.wiznia@einsteinmed.edu

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

Recruiting

Houston, Texas, United States, 77030

Contacts

Mary Paul

832-822-1038mpaul@bcm.edu

More Information

Sponsor

International Maternal Pediatric Adolescent AIDS Clinical Trials Group

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Keywords

  • Cefriaxone
  • Syphilis
  • Pregnancy
  • Benzathine Penicillin G

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by International Maternal Pediatric Adolescent AIDS Clinical Trials Group on 2026-08-06.