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CARES-1: Ambulatory Antibiotics for Congenital Syphilis
NCT06921213Phase 2
Key facts
- Status
- Recruiting
- Start
- May 2026
- Primary completion
- Mar 2027
- Countries
- 3
- Sponsor
- London School of Hygiene & Tropical Medicine
- Modality
- Small Molecules
- Drugs
- linezolidamoxicillin
- Conditions
- congenital syphilis (CS)
01
Overview
Phase 2, randomised, open-label trial of linezolid and amoxicillin in congenital syphilis (CS) (3 arms), sponsored by London School of Hygiene & Tropical Medicine. Primary endpoints: Time above Minimum Inhibitory Concentration in serum at 10 days, Time above Minimum Inhibitory Concentration in Cerebrospinal Fluid at 10 days and 1 more. Started May 2026; status: recruiting.
02
Design
3 arms- Study design
- RandomizedOpen-label
Oral Linezolid
10 day course of Linezolid twice a day
Oral Amoxicillin
10 day course of Amoxicillin twice a day
IM Benzathine penicillin
Single IM dose of IM Benzathine penicillin
03
Who it enrols
Neonates <= 7 days old with a post-menstrual age of 34-42 weeks, weighing >= 2kg, who are at risk of congenital syphilis but asymptomatic, and tolerating enteral feeds.
04
Endpoints
Primary
Time above Minimum Inhibitory Concentration in serum
Time above Minimum Inhibitory Concentration in Cerebrospinal Fluid
Adverse Events
Secondary
Clinical Outcome
Area Under the Curve to Minimum Inhibitory Concentration Ratio in serum
Area Under the Curve to Minimum Inhibitory Concentration Ratio in Cerebrospinal Fluid
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