Congenital Syphilis Treatment Trial (CONSISTENT) in Neonates

Conditions

• Syphilis, Congenital

Eligibility Criteria

Sex

ALL

Age

0 Days - 30 Days

Healthy Volunteers

Not accepted

Interventions

• Benzathine Penicillin — DRUG
  Standard of Care Treatment
• Amoxicillin — DRUG
  Amoxicillin given by mouth for 10 days

Study Details

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.

Key Dates

First listed

Mar 9, 2026

Start date

Nov 1, 2026

Status verified

Feb 2026

Primary completion

May 1, 2031

Completion

Aug 31, 2031

Study Design

Enrollment

374 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Active Comparator: Single Dose of BPG
  Neonates will receive a single dose of BPG as standard of care.
• Experimental: Study Medication (Amoxicillin)
  Neonates will receive Amoxicillin (Study Medication), twice a day for 10 days.

Primary Outcome Measure

Proportion of participants demonstrating a treatment efficacy of oral Amoxicillin BID X 10 days vs. BPG IM X1 by 6 months of age [ Time Frame: 6 months ]

Central Contacts

• Jill Griffin, MSN
  2056352537
  [email protected]
• Linda Austin
  2056382530
  [email protected]

Locations (11)

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