Actively Recruiting
Comprehensive Ambulatory Antibiotics for the Treatment of Congenital Syphilis
Led by London School of Hygiene and Tropical Medicine · Updated on 2026-05-11
90
Participants Needed
3
Research Sites
60 weeks
Total Duration
On this page
Sponsors
L
London School of Hygiene and Tropical Medicine
Lead Sponsor
U
University College Dublin
Collaborating Sponsor
AI-Summary
What this Trial Is About
CARES-1 is a randomised, open-label, phase II pharmacokinetic (PK) and safety study of ambulatory antibiotics for the treatment of neonates with "all-risk" asymptomatic congenital syphilis.
CONDITIONS
Official Title
Comprehensive Ambulatory Antibiotics for the Treatment of Congenital Syphilis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infants at risk of congenital syphilis at birth born to mothers who tested positive for syphilis during pregnancy using approved local tests
- Mothers untreated or inadequately treated for syphilis during current pregnancy or considered at risk of re-infection
- Infants asymptomatic for congenital syphilis based on clinical assessment
- Infants aged 7 days old or less with post-menstrual age between 34 and 42 weeks
- Infants tolerating enteral feeds, including via nasogastric tube
You will not qualify if you...
- Infants needing ongoing antibiotic treatment with potential anti-treponemal activity for more than 48 hours before randomization
- Infants with birth weight under 2 kg
- Infants unable to take food by mouth (nil by mouth)
- Infants with life-limiting congenital anomalies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Universitas Indonesia
Jakarta, Indonesia
Not Yet Recruiting
2
Malawi Liverpool Wellcome Programme
Blantyre, Malawi
Not Yet Recruiting
3
Stellenbosch
Stellenbosch, South Africa
Actively Recruiting
Research Team
S
Sarah Prentice
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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