Pregnant women needed for antibiotic safety study
NCT ID NCT07207876
First seen Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 2 times
Summary
This study looks at how two antibiotics, ceftriaxone and benzathine penicillin G, are processed by the body during pregnancy. Up to 78 pregnant women in the U.S. will take one of these drugs as part of their regular care, and researchers will measure drug levels in their blood. The goal is to find the right doses to treat infections safely for both mother and baby.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 110 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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A research network
The lead sponsor is a research network or cooperative group.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Women receiving or expecting to receive ceftriaxone for indications other than syphilis or benzathine penicillin G for treatment of syphilis during pregnancy in the United States (US). The infants of pregnant participants receiving benzathine penicillin G will also be enrolled.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
9 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Site 4001, Lurie Children's Hospital of Chicago (LCH) CRS
RECRUITINGChicago, Illinois, 60614, United States
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Site 5013, Jacobi Med. Ctr. Bronx NICHD CRS
RECRUITINGThe Bronx, New York, 10461, United States
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Site 5040, SUNY Stony Brook NICHD CRS
RECRUITINGStony Brook, New York, 11794, United States
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Site 5048, USC - Maternal Child Adolescent/Adult Center
RECRUITINGLos Angeles, California, 90033, United States
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Site 5083, Rush Univ. Cook County Hosp. Chicago NICHD CRS
NOT_YET_RECRUITINGChicago, Illinois, 60612, United States
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Site 5112, David Geffen School of Medicine at UCLA NICHD CRS
RECRUITINGLos Angeles, California, 90095, United States
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Site 5114, Bronx-Lebanon Hospital Center NICHD CRS
RECRUITINGThe Bronx, New York, 10457, United States
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Site 5128, Baylor College of Medicine/Texas Children's Hospital NICHD CRS
RECRUITINGHouston, Texas, 77030, United States
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Site 5129, IMPAACT/Gamma Project/UPR Pediatric HIV/AIDS Research CRS
RECRUITINGSan Juan, 00935, Puerto Rico
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