drugset / Trial / NCT06921213
Comprehensive Ambulatory Antibiotics for the Treatment of Congenital Syphilis
Phase 2
Recruiting
90 enrolled
London School of Hygiene and Tropical Medicine
MRC CTU at UCL · collabMalawi Liverpool Wellcome Programme · collabMurdoch Childrens Research Institute · collabPHPT/AMS Laboratory, Faculty of Associated Medical Sciences, Chiang Mai University · collabUniversity College Dublin · collabUniversity of Stellenbosch · collabUniversity of Sydney · collab
RandomizedParallel-groupSingle-blindTreatment
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.
Timeline
- Start
- 2026-05-04
- Primary completion
- 2027-03-31
- Completion
- 2027-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amoxicillin | Other / unclassified | 50 mg/kg | Oral |
| Comparator | Benzathine Penicillin G | Unknown | 50000 iu/kg | Intramuscular |
| Subject | Linezolid | Other / unclassified | 10 mg/kg | Oral |