Trials / Not Yet Recruiting
Not Yet RecruitingNCT06921213
Comprehensive Ambulatory Antibiotics for the Treatment of Congenital Syphilis
- Status
- Not Yet Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- Sponsor
- London School of Hygiene and Tropical Medicine · Academic / Other
- Sex
- All
- Age
- 0 Days – 7 Days
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Linezolid (LZD) | Ten day course. Oral Linezolid dosed at 10mg/kg twice a day. |
| DRUG | Amoxicillin | Ten day course. Oral Linezolid dosed at 50mg/kg twice a day. |
| DRUG | Benzathine Penicillin G | Single IM dose 50,000iu/kg |
Timeline
- Start date
- 2025-10-01
- Primary completion
- 2026-12-31
- Completion
- 2027-06-30
- First posted
- 2025-04-10
- Last updated
- 2025-05-04
Locations
3 sites across 3 countries: Indonesia, Malawi, South Africa
Source: ClinicalTrials.gov record NCT06921213. Inclusion in this directory is not an endorsement.