Health Trials

Comprehensive Ambulatory Antibiotics for the Treatment of Congenital Syphilis

ConditionSyphilis, Congenital
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age0-7
SponsorLondon School of Hygiene and Tropical Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

an infant born to a mother who tests positive for syphilis in pregnancy using registered and licensed locally-available diagnostic tests for example but not limited to a Treponemal rapid POCT, an RPR or both.

Infants who are asymptomatic for a diagnosis of congenital syphilis following application of a clinical proforma by the study team (Appendix 1)

Infants who are less than <= 7 days of life AND with a post-menstrual age (PMA) of 34-42 weeks (Appendix 2).

Infants who are tolerating enteral feeds, including if they are being administered by an NG tube.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Linezolid (LZD)

    Drug

    Ten day course. Oral Linezolid dosed at 10mg/kg twice a day.

  • Amoxicillin

    Drug

    Ten day course. Oral Linezolid dosed at 50mg/kg twice a day.

  • Benzathine Penicillin G

    Drug

    Single IM dose 50,000iu/kg

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Oral LinezolidExperimental treatment 1 intervention
Group B: Oral AmoxicillinExperimental treatment 1 intervention
Group C: IM Benzathine penicillinActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

Time above MIC in CSF

Time above MIC in CSF throughout the dosing interval

Time frame
10 days
3

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

Secondary outcomes

1

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
2

AUC/MIC Ratio in serum

Proportion of individuals achieving an AUC/MIC ratio ≥100 in serum

Time frame
Enrolment through to day 10
3

AUC/MIC Ratio in CSF

Proportion of individuals achieving an AUC/MIC ratio ≥100 in CSF

Time frame
Enrolment through to day 10

Other outcomes

Sponsors and contacts

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London School of Hygiene and Tropical Medicine

Lead sponsor

University College Dublin

Collaborator

University of Stellenbosch

Collaborator

Malawi Liverpool Wellcome Programme

Collaborator

University of Sydney

Collaborator

Murdoch Childrens Research Institute

Collaborator

MRC CTU at UCL

Collaborator

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

Collaborator

Source ClinicalTrials.gov
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