Study of Three Antibiotic Treatments for Newborns With Congenital Syphilis Including Oral Linezolid, Oral Amoxicillin, and Injection Benzathine Penicillin

What this Trial Is About

Researchers are studying ambulatory antibiotic treatments for neonates with all-risk asymptomatic congenital syphilis in a randomized, open-label phase II trial called CARES-1. The study aims to evaluate the pharmacokinetics and safety of different antibiotic options to improve treatment approaches for this vulnerable newborn population. Participants are randomly assigned to one of three treatment groups a 10-day course of oral Linezolid given twice daily at 10 mgkg, a 10-day course of oral Amoxicillin given twice daily at 50 mgkg, or a single intramuscular dose of Benzathine Penicillin G at 50,000 IUkg. These treatments are provided in an ambulatory setting to assess their effectiveness and tolerability in newborns. During the study, infants will be monitored from enrollment through day 10 for antibiotic levels in blood and cerebrospinal fluid, and adverse events will be tracked for up to 24 weeks. Clinical outcomes will be evaluated through week 24 to assess treatment impact. This includes measuring time above minimum inhibitory concentrations and AUCMIC ratios in serum and CSF. Safety and treatment effects will be closely observed throughout the study duration.

Comprehensive Ambulatory Antibiotics for the Treatment of Congenital Syphilis