South Africa is one of four countries where GARDP is engaged in a phase 3 trial to develop a treatment for gonorrhoea, which affects millions of people across the world every year.
As we mark STD Awareness Week from 11-17 April, the trial is underway at three sites in two of South Africa’s provinces. With our partner Entasis Therapeutics, GARDP is evaluating a novel antibiotic called zoliflodacin. As a first-in-class treatment, zoliflodacin is active against resistant strains of gonorrhea. Zoliflodacin has also been designed as an oral treatment option, which has the potential for significant benefits compared to the current standard of care of intramuscular injections.
The South African sites are encouraged to be part of a trial aimed at addressing such a pivotal public health challenge.
“If left untreated, gonorrhoea can have serious and permanent consequences, particularly for women, including infertility, life threatening ectopic pregnancies and pelvic inflammatory disease. We have the opportunity to work towards changing this trajectory,” said Sinead Delany-Moretlwe, the trial’s Principal Investigator in South Africa, based at the University of the Witwatersrand in Johannesburg.
Edward Mukwaya, GARDP Clinical Trial Manager in South Africa, said South Africa’s research experience holds it in good stead. “South Africa is a major global hub for conducting clinical trials due to the robust health research infrastructure, with highly motivated, skilled and experienced researchers, state of the art research institutions and the availability of large patient numbers across therapeutic areas.”
As the numbers of gonorrhoea cases rise globally, including in South Africa, working towards more testing and a new treatment is essential. Gonorrhoea is a common sexually transmitted infection (STI) affecting both men and women, particularly between 15 and 24 years old. There are an estimated 87 million new cases every year around the world.
Three sites in South Africa are taking part in the study – the Wits Reproductive Health and HIV Institute (Wits RHI) based at the Hillbrow Health Precinct in Johannesburg, and two South African Medical Research Council (SAMRC) sites at Tongaat and Botha’s Hill in South Africa’s KwaZulu-Natal province. The Sexually Transmitted Infections Section Centre at South Africa’s National Institute for Communicable Diseases is playing a leading role in testing and collating microbiological samples from the South African study sites, for quality control and shipment to the central lab in the USA.
The phase 3 trial is expected to enrol up to 1,000 adults with urogenital gonorrhoea from clinical trial sites in South Africa, the United States, Netherlands and Thailand.