Comprehensive Ambulatory Antibiotics for the Treatment of Congenital Syphilis

Launched by LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE · Apr 3, 2025

Keywords

ClinConnect Summary

The CARES-1 trial is a study looking at how well certain antibiotics work for treating newborns who might have congenital syphilis, which is a type of syphilis that can be passed from mother to baby during pregnancy. This study is for babies who are under 7 days old and are asymptomatic, meaning they do not show any signs of the disease. To be eligible, the babies must be born to mothers who tested positive for syphilis during pregnancy and did not receive proper treatment.

Participants in this trial will receive ambulatory antibiotics, which means they can be treated while staying with their families rather than in a hospital. The study is currently not recruiting participants, but it aims to gather important information about the safety and effectiveness of these antibiotics for young infants. This is crucial for developing better treatment options for congenital syphilis, helping to ensure healthier outcomes for newborns at risk.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• 1. Infants at risk of congenital syphilis at birth defined as:
• • 1. 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.
• • AND
• 2. the mother is untreated in the current pregnancy defined as:
• • i. she tested positive at antenatal care and received no treatment OR ii. she was never tested during antenatal care OR iii. she tested negative at antenatal care and positive on re-testing at delivery
• OR c. the mother is inadequately treated in the current pregnancy defined as:
• • i. Having received a non-penicillin based treatment regimen; and/or ii. Does not have documentation of 3 doses of IM Benzathine Penicillin, given 7-10 days apart, with the last dose given \> 30 days prior to delivery OR b. The mother was adequately treated in the current pregnancy BUT considers herself at risk of re-infection following a midwife delivered explanation of risk (partner treatment, multiple partners etc).
• • 2. Infants who are asymptomatic for a diagnosis of congenital syphilis following application of a clinical proforma by the study team (Appendix 1)
• • 3. Infants who are less than \<= 7 days of life AND with a post-menstrual age (PMA) of 34-42 weeks (Appendix 2).
• • 4. Infants who are tolerating enteral feeds, including if they are being administered by an NG tube.
• Exclusion Criteria:
• • - 1. The infant's clinical condition at birth or prior to randomisation requires ongoing (\> 48 hours) treatment with antibiotics with the potential for anti-treponemal activity i.e. B-lactams, Cephalosporins, Carbapenems.
• • 2. They have a birthweight \<2kg 3. They are nil by mouth. 4. They have a life-limiting congenital anomaly