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.
an infant born to a mother who tests positive for syphilis in pregnancy using registered and licensed locally-available diagnostic tests for example but not limited to a Treponemal rapid POCT, an RPR or both.
Infants who are asymptomatic for a diagnosis of congenital syphilis following application of a clinical proforma by the study team (Appendix 1)
Infants who are less than <= 7 days of life AND with a post-menstrual age (PMA) of 34-42 weeks (Appendix 2).
Infants who are tolerating enteral feeds, including if they are being administered by an NG tube.
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London School of Hygiene and Tropical Medicine
Lead sponsor
University College Dublin
Collaborator
University of Stellenbosch
Collaborator
Malawi Liverpool Wellcome Programme
Collaborator
University of Sydney
Collaborator
Murdoch Childrens Research Institute
Collaborator
MRC CTU at UCL
Collaborator
PHPT/AMS Laboratory, Faculty of Associated Medical Sciences, Chiang Mai University
Collaborator