South Africa is one of four countries which is involved in a global phase 3 trial to assess the efficacy and safety of zoliflodacin, a new treatment for gonorrhoea, against standard treatments.
Three sites across two provinces in South Africa are set to take part in the study. One of them is the Wits Reproductive Health and HIV Institute (Wits RHI), which is based at the Hillbrow Health Precinct in Johannesburg. Wits RHI is part of the Faculty of Health Sciences at the University of the Witwatersrand and is one of the leading multi-disciplinary institutes in Africa. It has been involved in numerous trials, including of vaccines and treatments in the fields of infectious diseases such as HIV, TB and several STIs.
Two South African Medical Research Council (SAMRC) sites at Tongaat and Botha’s Hill in South Africa’s KwaZulu-Natal province will also take part in the study. The SAMRC is a statutory body under the national Department of Health and has undertaken numerous clinical trials over the past 20 years.
GARDP has partnered with the University of KwaZulu-Natal’s Department of Medical Microbiology for the laboratory aspect of the clinical trial. The vision is that the work on the trial will contribute to building diagnostic and research capacity in this region, and ultimately enhance disease and resistance surveillance while enabling future trials national laboratory STI program.
The Sexually Transmitted Infections Section Centre for HIV & STI at the National Institute for Communicable Diseases (NICD) acts as the national reference laboratory for HIV and STIs in South Africa. It is located in Johannesburg and is responsible for gonococcal resistance surveillance in the country. It will play a leading role in central NAAT testing and collating microbiological samples from the South African Zoliflodacin study sites, for quality control and shipment to the central lab in the USA.