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NOT YET RECRUITING
NCT06921213
PHASE2

Comprehensive Ambulatory Antibiotics for the Treatment of Congenital Syphilis

Sponsor: London School of Hygiene and Tropical Medicine

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

0 Days - 7 Days

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2025-10-01

Completion Date

2027-06-30

Last Updated

2025-05-04

Healthy Volunteers

No

Interventions

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

Locations (3)

Universitas Indonesia

Jakarta, Indonesia

Malawi Liverpool Wellcome Programme

Blantyre, Malawi

Stellenbosch

Stellenbosch, South Africa