Congenital Syphilis Treatment Trial (CONSISTENT) in Neonates
Public ClinicalTrials.gov record NCT07457385. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Congenital Syphilis Treatment Trial (CONSISTENT): Phase IV, Open-label, Randomized Controlled Trial of Amoxicillin vs. Benzathine in Neonates With Possible Congenital Syphilis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The Investigator hypothesize that the treatment efficacy will be similar in both study arms. Secondary outcomes and endpoints will characterize safety by comparing adverse events (AEs), tolerability, and adherence to therapy in each arm. This is a Phase 4, open-label, multicenter trial designed to evaluate the efficacy of a single injected dose of intramuscular (IM) BPG (Arm 1) compared to oral amoxicillin administered twice daily (BID) for 10 days (Arm 2). The study will involve infants aged ≤ 30 days old with suspected untreated syphilis. The trial will be conducted at 12 sites across the U.S., enrolling approximately 374 participants. Upon randomization, participants will undergo baseline study sample collection (blood, oropharyngeal, and nasal mucosal swabs for PCR testing) and then receive either treatment with oral amoxicillin or IM BPG, both with directly observed therapy. The participant enrolled in the optional pharmacokinetic (PK) sub-study will have additional blood samples collected for PK analysis within the first 24-48 hours after treatment. Participants will be discharged from the hospital following routine procedures, with the oral amoxicillin dosing continued at home (BID) by the caregiver.
Study identification
- NCT ID
- NCT07457385
- Recruitment status
- Not yet recruiting
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 374 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 0 Days to 30 Days
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 1, 2026 (Estimated)
- Primary completion
- May 1, 2031 (Estimated)
- Completion
- Aug 31, 2031 (Estimated)
- Last update posted
- Sep 2, 2026
2026 – 2031
United States locations
- U.S. sites
- 11
- U.S. states
- 9
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | — |
| University of South Alabama Medical Center | Mobile | Alabama | 36617 | — |
| Children's Hospital of Orange County | Orange | California | 92868 | — |
| University of South Florida | Tampa | Florida | 33606 | — |
| LSU Health Sciences Center-Shrevport | Shreveport | Louisiana | 71103 | — |
| Washington University-St.Louis | St Louis | Missouri | 63310 | — |
| University of New Mexico | Albuquerque | New Mexico | 87106 | — |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| Avera McKennan University Health Center | Sioux Falls | South Dakota | 57105 | — |
| University of Texas-Southwestern Medical Center at Dallas | Dallas | Texas | 75390 | — |
| Baylor College of Medicine-Texas Children's Hospital | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07457385, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 2, 2026 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07457385 live on ClinicalTrials.gov.