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Clinical Trials in Mexico / NCT07457385
Starting soon Phase 4

Congenital Syphilis Treatment Trial (CONSISTENT) in Neonates

NCT07457385 · tracked via the Priya Life Science Mexico tracker
Sponsor
University of Alabama at Birmingham
Phase
Phase 4
Started
2026-11-01
Last updated
2026-09-02

Condition(s) studied

Syphilis, Congenital

Investigational drug(s) / intervention(s)

Benzathine Penicillin →Amoxicillin →

Benzathine Penicillin: Standard of Care Treatment

Amoxicillin: Amoxicillin given by mouth for 10 days

Study summary

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.

Eligibility

Sex
ALL
Min age
0 Days
Max age
30 Days
Healthy volunteers
No
Inclusion Criteria: 1. Confirmed staged maternal syphilis in pregnancy with rapid plasma reagin (RPR) + and T. pallidum hemagglutination antibody (TPHA) or other evidence of active syphilis (i.e. ulcerative anogenital lesion with positive darkfield microscopy or PCR+ for T. pallidum) 2. Inadequate therapy (non-BPG regimen, incomplete regimen for stage, \<30 days prior to delivery), undocumented therapy, or lack of maternal syphilis therapy in pregnancy 3. Infant age ≤ 30 days old 4. Gestational age at birth ≥35 weeks 5. Infant birth weight ≥ 750 grams 6. Infant tolerating oral feeds 7. Normal infant examination, laboratory, and radiographic evaluation: hemoglobin, platelet count, CSF (cell count, protein, VDRL), long-bone radiographs 8. Infant quantitative RPR reactive and ≤ 4-fold lower titer compared with maternal RPR 9. Parent(s) or legal guardian(s) capable and willing to provide informed consent Exclusion Criteria: 1. Infant receipt of antibiotics between birth and enrollment with activity against T. pallidum (including beta-lactam, cephalosporin, or azithromycin) 2. Uncontrolled maternal HIV (viral load \>1000 copies/mL at or within 4 weeks of delivery) or HIV-exposed infants who require three drug antiretroviral post exposure prophylaxis. 3. Unable to ensure infant follow up through six months of age

Primary outcome measure(s)

  • Proportion of participants demonstrating a treatment efficacy of oral Amoxicillin BID X 10 days vs. BPG IM X1 by 6 months of age — 6 months
    Proportion with serologic response defined as RPR titer reversion to non-reactive or a four-fold decline in titer within one to six months after treatment.

Trial sites (11)

FacilityCityRegionStatus
University of Alabama at Birmingham Birmingham Alabama
University of South Alabama Medical Center Mobile Alabama
Children's Hospital of Orange County Orange California
University of South Florida Tampa Florida
LSU Health Sciences Center-Shrevport Shreveport Louisiana
Washington University-St.Louis St Louis Missouri
University of New Mexico Albuquerque New Mexico
Children's Hospital of Philadelphia Philadelphia Pennsylvania
Avera McKennan University Health Center Sioux Falls South Dakota
University of Texas-Southwestern Medical Center at Dallas Dallas Texas
Baylor College of Medicine-Texas Children's Hospital Houston Texas

On this site

📄 Amoxil (amoxicillin) drug profile →

More University of Alabama at Birmingham trials in Mexico

Epidemiology and Processes of Care for Renal Replacement Therapy in Acute Kidney Injury in Latin America Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07457385 on ClinicalTrials.gov ↗ ← All trials in Mexico