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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
90
Ten day course. Oral Linezolid dosed at 10mg/kg twice a day.
Ten day course. Oral Linezolid dosed at 50mg/kg twice a day.
Single IM dose 50,000iu/kg
Universitas Indonesia
Jakarta, Indonesia
Malawi Liverpool Wellcome Programme
Blantyre, Malawi
Stellenbosch
Stellenbosch, South Africa
Time above MIC in serum
Time above MIC of T. pallidum for the dosing interval in serum
Time frame: From enrolment through to day 10 of the study
Time above MIC in CSF
Time above MIC in CSF throughout the dosing interval
Time frame: 10 days
Adverse Events
The proportion of individuals experiencing an adverse event through to week 24. The trial will record SAE, SUSARS, and drug related AEs of grade 3 or higher.
Time frame: Assessed from enrolment through to 24 weeks
Clinical Outcome
Proportion of infants who have clinical or laboratory evidence of congenital syphilis as adjudicated by an expert committee, blinded to treatment allocation, based on clinical and laboratory data.
Time frame: Enrolment through to week 24
AUC/MIC Ratio in serum
Proportion of individuals achieving an AUC/MIC ratio ≥100 in serum
Time frame: Enrolment through to day 10
AUC/MIC Ratio in CSF
Proportion of individuals achieving an AUC/MIC ratio ≥100 in CSF
Time frame: Enrolment through to day 10
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