Ceftriaxone and benzathine penicillin G use during pregnancy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

IMPAACT 2044 is a Phase IV, multi-site, open-label, non-randomized, opportunistic study that will measure pharmacokinetics and safety of ceftriaxone and benzathine penicillin G during pregnancy. Up to 78 pregnant women who are already being treated with IV or IM ceftriaxone (for non-syphilis indications) or IM benzathine penicillin G (for syphilis) will be enrolled, and about 22 infants of participants receiving benzathine penicillin G will also be followed. Participants are assigned to Arm 1 (ceftriaxone, subdivided into IV and IM groups) or Arm 2 (IM benzathine penicillin G) based on the antibiotic prescribed by their clinical provider, with no randomization. The study collects blood samples and safety data around routine clinical care visits to characterize drug levels and monitor mother and infant safety.

Why it matters

Who can join: the full rules

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

Where it's running

• Site 5048, USC - Maternal Child Adolescent/Adult Center
  Los Angeles, California, United States Recruiting
• Site 5112, David Geffen School of Medicine at UCLA NICHD CRS
  Los Angeles, California, United States Recruiting
• Site 4001, Lurie Children's Hospital of Chicago (LCH) CRS
  Chicago, Illinois, United States Recruiting
• Site 5040, SUNY Stony Brook NICHD CRS
  Stony Brook, New York, United States Recruiting
• Site 5114, Bronx-Lebanon Hospital Center NICHD CRS
  The Bronx, New York, United States Recruiting
• Site 5013, Jacobi Med. Ctr. Bronx NICHD CRS
  The Bronx, New York, United States Recruiting

Study contacts

• Study coordinator: Lisa Levy
• Email: impaact.ctgov@fstrf.org
• Phone: 2028848480

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Pregnant Women Living with HIV on Bictegravir/Emtricitabine/Tenofovir Alafenamide

  This study looks at how B/F/TAF is used in pregnant women with HIV and whether it helps maintain viral suppression from before conception through delivery.

  Recruiting Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida · Paris · NCT07921472

• Pelvic Floor Training and a Modified Lumbopelvic Belt for Symphysis Pubis Pain in Pregnancy

  This study tests whether pelvic floor muscle training plus a modified lumbopelvic belt can reduce pain and improve function for pregnant women with symphysis pubis pain.

  Recruiting Kahramanmaras Sutcu Imam University · Kahramanmaraş · NCT07919548

• Effective Communication in VBAC Counseling

  This study tests how clearly doctors and midwives explain VBAC options during prenatal visits and whether patients feel understood.

  Recruiting IRCCS San Raffaele · Milan, MI · NCT07919145

• Innovative Multidisciplinary and Virtual Care for IBD in Pregnancy

  This study tests a dedicated IBD pregnancy care model, including a new virtual approach, to see if it improves access and quality of care for pregnant people with Crohn's disease or ulcerative colitis.

  Recruiting at 5 sites Austin Health · Hobart and 6 other locations · NCT07916727

• Compare spinal-epidural versus general anesthesia for babies after cesarean delivery

  This trial tests whether the type of anesthesia used for cesarean delivery affects newborn hearing in babies.

  Recruiting Second Affiliated Hospital of Wenzhou Medical University · Wenzhou · NCT07852624

• Pregnant women weight-management support via an app and care model

  Aims to try a smartphone-based weight-management program plus professional support for pregnant women to see if it helps manage gestational weight and promote healthy behaviors.

  Recruiting Mackay Medical College · Taipei · NCT07814885

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.