Study of Ceftriaxone and Benzathine Penicillin G During Pregnancy

Part of paid clinical trials in Los Angeles, California.

Sponsor
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Study ID
NCT07207876
Status
Recruiting
Apply to this trial

Conditions

  • Pregnancy

Eligibility Criteria

Sex
FEMALE
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ceftriaxon — DRUG
    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 — DRUG
    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

Study Details

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.

Key Dates

Start date
Feb 16, 2026
Status verified
Mar 2026
Primary completion
Aug 29, 2026
Completion
May 17, 2027

Study Design

Enrollment
110 participants (estimated)

Arms

  • Arm: Active comparator: Arm 1A: IV ceftriaxone
    Intravenous ceftriaxone
  • Arm: Active Comparator: Arm 1B: IM ceftriaxone
    Intramuscular ceftriaxone
  • Arm: Active Comparator: Arm 2: IM benzathine penicillin G
    Intramuscular benzathine penicillin G

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 ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Site 5048, USC - Maternal Child Adolescent/Adult CenterLos AngelesCalifornia90033
Alice Stek
[email protected]
323-865-1585
Site 5112, David Geffen School of Medicine at UCLA NICHD CRSLos AngelesCalifornia90095
Jaime Deville
[email protected]
310-825-9660
Site 4001, Lurie Children's Hospital of Chicago (LCH) CRSChicagoIllinois60614
Jennifer Jao
[email protected]
312-227-4080
Site 5083, Rush Univ. Cook County Hosp. Chicago NICHD CRSChicagoIllinois60612
Miriam Aziz
[email protected]
312-572-4265
Site 5040, SUNY Stony Brook NICHD CRSStony BrookNew York11794
Sharon Nachman
[email protected]
631-444-7692
Site 5013, Jacobi Med. Ctr. Bronx NICHD CRSThe BronxNew York10461
Andrew Wiznia
[email protected]
718-918-4664
Site 5114, Bronx-Lebanon Hospital Center NICHD CRSThe BronxNew York10457
Murli Purswani
[email protected]
718-960-1010
Site 5128, Baylor College of Medicine/Texas Children's Hospital NICHD CRSHoustonTexas77030
Mary Paul
[email protected]
832-822-1038

Find similar trials in Los Angeles, CA

By research site
Site 5048, USC - Maternal Child Adolescent/Adult Center· Los Angeles, CASite 5112, David Geffen School of Medicine at UCLA NICHD CRS· Los Angeles, CASite 4001, Lurie Children's Hospital of Chicago (LCH) CRS· Chicago, ILSite 5083, Rush Univ. Cook County Hosp. Chicago NICHD CRS· Chicago, ILSite 5040, SUNY Stony Brook NICHD CRS· Stony Brook, NYSite 5013, Jacobi Med. Ctr. Bronx NICHD CRS· The Bronx, NY

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