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Comprehensive Ambulatory Antibiotics for the Treatment of Congenital Syphilis

Study acronym: Cares-1
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Site details revised at 1 of 3 sites
    • Collaborators revised (7)
    v5
  2. Site details revised at 1 of 3 sitesv4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 1, 2025 to May 4, 2026
    • Primary completion date: Dec 31, 2026 to Mar 31, 2027
    • Site details revised at 3 of 3 sites
    v3
  4. Secondary endpoints: 4 to 3v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06921213
Lead Sponsor London School of Hygiene and Tropical Medicine
Collaborators: University College Dublin, University of Stellenbosch, Malawi Liverpool Wellcome Programme, University of Sydney, Murdoch Childrens Research Institute, University College, London, PHPT/AMS Laboratory, Faculty of Associated Medical Sciences, Chiang Mai University
Conditions
(from sponsor)		 Syphilis, Congenital
Related terms Syphilis, Congenital
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov