Comprehensive Ambulatory Antibiotics for the Treatment of Congenital Syphilis

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

• Syphilis, Congenital

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

Sponsors & Collaborators

• University College Dublin

  collaborator OTHER

• University of Stellenbosch

  collaborator OTHER

• Malawi Liverpool Wellcome Programme

  collaborator OTHER

• University of Sydney

  collaborator OTHER

• Murdoch Childrens Research Institute

  collaborator OTHER

• MRC CTU at UCL

  collaborator UNKNOWN

• PHPT/AMS Laboratory, Faculty of Associated Medical Sciences, Chiang Mai University

  collaborator UNKNOWN

• London School of Hygiene and Tropical Medicine

  lead OTHER

Principal Investigators

• Michael Marks · London School of Hygiene and Tropical Medicine

• Bridget Freyne · University College Dublin

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

0 Days

Max Age

7 Days

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-04

Primary Completion

2027-03-31

Completion

2027-06-30

Countries

• Indonesia
• Malawi
• South Africa

Study Locations