Congenital Syphilis – NeoTREP

A prospective surveillance study to understand clinical outcomes in Treponema pallidum (syphilis)-exposed neonates and infants

This prospective, multicentre observational study funded by the National Health and Medical Research Council, and in partnership with the ‘Prevent Syphilis Global Network’ aims to address the urgent need for prospective surveillance data on treatment practices and outcomes for congenital syphilis in high-burden regions of the Asia-Pacific and Southern African Countries. By collecting anonymised clinical data from syphilis-exposed infants, this study will evaluate current prescribing practices, the prevalence of adverse outcomes associated with non-penicillin strategies to treat CS and outcomes for syphilis-exposed infants. Surveillance will enable the identification of gaps in the availability of syphilis diagnostic tests as well as the impact of global penicillin shortages, which are impacting the treatment of both mothers and babies with congenital syphilis at present.

Why is this prospective surveillance needed?

Congenital syphilis (CS) is a significant global health issue, particularly in resource-constrained regions where access to antenatal care, timely diagnosis and accessible treatment can be challenging. Despite global elimination efforts, CS remains a leading cause of preventable stillbirth, neonatal mortality, and adverse health outcomes, with numbers rising over recent years.

Critical shortages of penicillin compound the high global burden of CS, the first-line treatment for both mothers and infants exposed to Treponema pallidum, the bacteria responsible for syphilis. These shortages pose substantial challenges to the effective management and prevention of CS. Alternative treatment options and their clinical outcomes remain poorly understood, with limited observational data to guide treatment decisions in the context of global penicillin shortages.

What is involved in this study?

Embedded within the NeoSEAP prospective study, this project enrols infants with suspected or confirmed congenital syphilis. Data are collected from the electronic clinical record to ascertain what investigations have been performed and what treatments are provided. Follow-up data are collected at discharge, 28 days and 12 months following enrolment to determine long-term health and developmental outcomes for infants with congenital syphilis.  These data will help to inform the burden of congenital syphilis and inform clinical trials to identify alternative treatment options for the management of congenital syphilis globally.

More information on Congenital Syphilis is available from the Prevent Syphilis Global Network website: https://www.preventsyphilis.org/