NCT06921213 Comprehensive Ambulatory Antibiotics for the Treatment of Congenital Syphilis
| NCT ID | NCT06921213 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | London School of Hygiene and Tropical Medicine |
| Condition | Syphilis, Congenital |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2026-05-04 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 90 participants in total. It began in 2026-05-04 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Michael Marks
PRINCIPAL INVESTIGATOR
London School of Hygiene and Tropical Medicine
Frequently Asked Questions
Who can join the NCT06921213 clinical trial?
This trial is open to participants of all sexes, aged 0 Days or older, up to 7 Days, studying Syphilis, Congenital. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06921213 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06921213 currently recruiting?
Yes, NCT06921213 is actively recruiting participants. Contact the research team at sarah.prentice@lshtm.ac.uk for enrollment information.
Where is the NCT06921213 trial being conducted?
This trial is being conducted at Jakarta, Indonesia, Blantyre, Malawi, Stellenbosch, South Africa.
Who is sponsoring the NCT06921213 clinical trial?
NCT06921213 is sponsored by London School of Hygiene and Tropical Medicine. The principal investigator is Michael Marks at London School of Hygiene and Tropical Medicine. The trial plans to enroll 90 participants.