Outpatient antibiotic options for newborns with congenital syphilis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

CARES-1 is a randomized, open-label phase II pharmacokinetic and safety study of ambulatory antibiotic regimens for neonates born at risk of asymptomatic congenital syphilis. Eligible newborns are randomized to receive outpatient courses that include linezolid, amoxicillin, or benzathine penicillin G, with serial drug-level measurements and safety monitoring. The study records pharmacokinetics, adverse events, and short-term clinical outcomes to determine if outpatient dosing reaches therapeutic concentrations and is well tolerated. The trial is led by the London School of Hygiene and Tropical Medicine with collaborating sites in Indonesia, Malawi, and South Africa.

Why it matters

Who can join: the full rules

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

Where it's running

• Universitas Indonesia
  Jakarta, Indonesia Recruiting
• Malawi Liverpool Wellcome Programme
  Blantyre, Malawi Recruiting
• Stellenbosch
  Stellenbosch, South Africa Recruiting

Study contacts

• Principal investigator: Michael Marks — London School of Hygiene and Tropical Medicine
• Study coordinator: Sarah Prentice
• Email: sarah.prentice@lshtm.ac.uk
• Phone: +4420 7636 8636

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.